GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 68955-20-4
Chemical Name Sodium alkyl sulfate (alkyl C=16-18)
Substance ID H28-B-11-METI, M-013B
Classification year (FY) FY2016
Ministry who conducted the classification Ministry of Economy, Trade and Industry (METI)/Ministry of the Environment (MOE)
New/Revised Revised
Classification result in other fiscal year FY2008  
Download of Excel format Excel file

REFERENCE INFORMATION
Item Information
Guidance used for the classification (External link) GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
UN GHS document (External link) UN GHS document
Definitions/Abbreviations (Excel file) Definitions/Abbreviations
Model Label by MHLW (External link) MHLW Website (in Japanese Only)
Model SDS by MHLW (External link) MHLW Website (in Japanese Only)
OECD/eChemPortal (External link) eChemPortal

PHYSICAL HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
1 Explosives Not applicable
-
-
- -  There are no chemical groups associated with explosive properties present in the molecule.
2 Flammable gases (including chemically unstable gases) Not applicable
-
-
- -  Solid (GHS definition).
3 Aerosols Not applicable
-
-
- -  Not aerosol products.
4 Oxidizing gases Not applicable
-
-
- -  Solid (GHS definition).
5 Gases under pressure Not applicable
-
-
- -  Solid (GHS definition).
6 Flammable liquids Not applicable
-
-
- -  Solid (GHS definition).
7 Flammable solids Classification not possible
-
-
- -  No data available.
8 Self-reactive substances and mixtures Not applicable
-
-
- -  There are no chemical groups present in the molecule associated with explosive or self-reactive properties.
9 Pyrophoric liquids Not applicable
-
-
- -  Solid (GHS definition).
10 Pyrophoric solids Classification not possible
-
-
- -  No data available. Besides, there is the autoignition temperature information of > 400 deg C (SIDS Dossier (2009)) although it is rated as reliability 4 (reliability not assignable).
11 Self-heating substances and mixtures Classification not possible
-
-
- -  Test methods applicable to solid (melting point <= 140 deg C) substances are not available.
12 Substances and mixtures which, in contact with water, emit flammable gases Not applicable
-
-
- -  The chemical structure of the substance does not contain metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).
13 Oxidizing liquids Not applicable
-
-
- -  Solid (GHS definition).
14 Oxidizing solids Classification not possible
-
-
- -  The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded to the element other than carbon or hydrogen (S, Na), but the classification is not possible due to no data.
15 Organic peroxides Not applicable
-
-
- -  Organic compounds containing no bivalent -O-O- structure in the molecule
16 Corrosive to metals Classification not possible
-
-
- -  Test methods applicable to solid substances are not available.

HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
1 Acute toxicity (Oral) Not classified
-
-
- -  There are 2 reports of LD50 values for rats, > 1,886 mg/kg (OECD TG 401) (SIDS (2009)) and > 1,100 mg/kg (Directive 79/831/EEC, Annex V, part B) (SIDS (2009)). Although, in these 2 reports, decreased motility and salivation were observed, no death cases were observed. In addition, also in the results of necropsy, no toxicological findings attributed to this substance were observed (SIDS (2009)).
 Moreover, based on these data, the LD50 value of the oral administration of this substance was set to be "greater than 2,000 mg/kg" in SIDS (2009)
 From the above, this substance was classified as "Not classified" (Category 5 in UN GHS classification) based on expert judgment.
1 Acute toxicity (Dermal) Classification not possible
-
-
- -  Classification not possible due to lack of data.
1 Acute toxicity (Inhalation: Gases) Not applicable
-
-
- -  Solid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Not applicable
-
-
- -  Solid (GHS definition)
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible
-
-
- -  Classification not possible due to lack of data.
2 Skin corrosion/irritation Classification not possible
-
-
- -  Classification not possible due to lack of data.
 There are 2 reports of skin irritation studies (OECD TG 404) using rabbits. It is reported that as a result of applying 25% of this substance for 4 hours, edema and erythema were observed, but that the recovery was within 7 days (SIDS (2009), BUA 189 (1996)). It is also reported that as a result of applying 55% of this substance, slight irritation was observed (BUA 189 (1996)). Moreover, in other study using rabbits, it is reported that as a result of 4-hour semi-occlusive application of 31.5% of this substance, slight irritation was observed (SIDS (2009)).
 All studies were conducted at low concentrations, so it is thought that they would indicate more reactivity at higher concentrations. However, they were judged to be insufficient data for use in classification. IUCLID information in the previous classification could not be confirmed because it was not available. The classification was revised because the information was updated.
3 Serious eye damage/eye irritation Category 2A


Warning
H319 P305+P351+P338
P337+P313
P264
P280
 There are 2 reports of eye irritation studies (OECD TG 405) using rabbits. It is reported that as a result of applying 25% of this substance, corneal opacity, erythema, conjunctival edema and exudation were observed, but that the recovery was within 10 days (SIDS (2009)).
 It is also reported that as a result of applying 55% of this substance, it was irritating since moderate to strong corneal and conjunctival reactions were found (BUA 189 (1996)). Moreover, in 2 other reports on eye irritation tests using rabbits, it is reported that as a result of applying 5% of this substance, slight to moderate irritation was observed, but the recovery was within 12 days. Therefore, it was reported as this was moderate to irritation (SIDS (2009)).
 As both studies were conducted at low concentrations, it is thought that this indicates more reactivity at higher concentrations. Therefore, this substance was classified in Category 2A. IUCLID information in the previous classification could not be confirmed because it was not available. The classification was revised because the information was updated.
4 Respiratory sensitization Classification not possible
-
-
- -  Classification not possible due to lack of data.
4 Skin sensitization Not classified
-
-
- -  It is reported that in a skin sensitization test (Directive 79/831/EWG, Annex V, Part B) using 20 guinea pigs, sensitization by this substance was not observed (SIDS (2009)). Also, it is reported that in another skin sensitization test using 20 guinea pigs, sensitization by this substance was not observed (SIDS (2009)). It is reported that as a result of patch tests in 97 volunteers, sensitization by this substance was not observed (SIDS (2009)).
 From the above, it was determined that this substance was classified as "Not classified."
5 Germ cell mutagenicity Classification not possible
-
-
- -  As for in vivo data, micronucleus tests using mice were negative (SIDS (2009), BUA (1996)). As for in vitro, bacterial reverse mutation tests were also negative (SIDS (2009), BUA (1996)). Therefore, this substance was classified as "Classification not possible" according to the GHS classification guidance for the Japanese Government.
6 Carcinogenicity Classification not possible
-
-
- -  Classification not possible due to lack of data.
 Besides, for sodium C12-15 alkyl sulfate (CAS 68890-70-0), it is described that in a 2-year carcinogenicity study using rats administered by feeding, no evidence of carcinogenicity was observed (SIDS (2009)).
7 Reproductive toxicity Classification not possible
-
-
- -  In a developmental toxicity study in pregnant rats administered by gavage during the period of organogenesis, no developmental toxicity was observed in fetuses at up to 675 mg/kg/day, where suppression in body weight gain and diarrhoea were observed in maternal animals (SIDS (2009)).
 However, because there is no information on the effects on fertility and sexual function, the classification was not possible due to lack of data.
8 Specific target organ toxicity - Single exposure Classification not possible
-
-
- -  Classification not possible due to lack of data.
 There is no single exposure data on this substance in humans.
 As for experimental animals, it is reported that in a single oral dose study using rats, decreased motility and salivation were observed at 2,000 mg/kg (SIDS Dossier (2009)). However, it was insufficient to identify target organs. Therefore, this substance was classified as "Classification not possible."
9 Specific target organ toxicity - Repeated exposure Classification not possible
-
-
- -  There is no information on humans.
 As for experimental animals, in a 13-week repeated dose toxicity study using rats administered by feeding, at a dose of 230 mg/kg/day which is above Category 2, an increase in liver weights and hypertrophy of hepatocytes were observed. Moreover, in a 13-week repeated dose toxicity study using rats administered by gavage, at a dose of 165 mg/kg/day (converted guidance value: 119 mg/kg/day) which is above Category 2, an increase in liver weights, increase in ALT activity and mild irritation changes in the stomach were observed (SIDS (2009)). On the other hand, in a 3-week repeated dose toxicity study using rats administered by feeding, at a dose of 417 mg/kg/day (converted guidance value: 97.3 mg/kg/day) which is equivalent to Category 2, hypertrophy of hepatocytes and increase in ALT and LDH activity were observed (SIDS (2009)).
 As described above, it is thought that the liver is the target organ, but in the 13-week studies, effects were observed only at doses above Category 2, and in the 3-week study, it was observed at a dose near the upper limit of Category 2.
 Therefore, this substance was classified as "Classification not possible" based on the 13-week test results which are more suitable for using for GHS classification.

10 Aspiration hazard Classification not possible
-
-
- -  Classification not possible due to lack of data.

ENVIRONMENTAL HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
11 Hazardous to the aquatic environment (Acute) Category 2
-
-
H401 P273
P501
 From 96-hour LC50 = 5.2 mg/L for fish (Danio rerio) (SIDS, 2007), it was classified in Category 2.
11 Hazardous to the aquatic environment (Long-term) Category 2


-
H411 P273
P391
P501
 Reliable chronic toxicity data were not obtained. Because rapid degradability data were not obtained, and it was classified in Category 2 for acute toxicity, it was classified in Category 2.
12 Hazardous to the ozone layer Classification not possible
-
-
- -  No data available.


NOTE:
* A blank or "-" in a cell of classification denotes that the classification of the hazard class was not conducted.
* Hazard_statement_and/or_Precautionary_statement will show when hovering the mouse over a code of Hazard_statement_and/or_Precautionary_statement.
Hazard_statement_and/or_Precautionary_statement are also provided in the Excel file.
* Classification was conducted by relevant Japanese Ministries in accordance with GHS Classification Guidance for the Japanese Government,
and is intended to provide a reference for preparing GHS labelling and SDS for users.
* This is a provisional English translation of classification results and is subject to revision without notice.
* The responsibility for any resulting GHS labelling and SDS referenced from this site is with users.
* Codes assigned to each of the hazard statements and codes for each of the precautionary statement are
based on the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) in United Nations.

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