Disodium (Z)-4-(9-octadecenylamino)-4-oxo-2(or 3)-sulphonatobutyrate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

2012-2013

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to GLP and valid testing guidelines, therefore it is considered relevant, adequate and reliable for classification.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Butanoic acid, 4-amino-4-oxo-2(or 3)-sulfo-, N-(C16-C18 (even numbered), C18 unsaturated alkyl), disodium salts

IUPAC Name:

Butanoic acid, 4-amino-4-oxo-2(or 3)-sulfo-, N-(C16-C18 (even numbered), C18 unsaturated alkyl), disodium salts

Test material form:

other: liquid to pasty

Details on test material:

- Name of test material (as cited in study report): Butanoic acid, 4-amino-4-oxo-2(or 3)-sulfo-, N-(C16-C18 (even numbered), C18unsaturated alkyl)), disodium salts; Sodium tallow sulphosuccinates
- Physical state: Liquid to pasty; opaque
- Analytical purity: 25.5% active matter (correction factor 3.92)
- Impurities (identity and concentrations): See confidential details
- Composition of test material, percentage of components: See confidential details
- Purity test date: February 16, 2012 CoA
- Lot/batch No.: MIBX042332
- Expiration date of the lot/batch: Retest date February 14, 2013
- Stability under test conditions: Stability test date February 14, 2012
- Storage condition of test material: At +10°C to +25 °C
- Other: Manufacturer/supplier: Huntsman Holland BV, Merseyweg 10, 3197 KG Botlek-Rotterdam, The Netherlands

Test animals

Species:

rat

Strain:

other: Crl:CD(SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories Germany GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at dosing: Approx. 8 weeks
- Weight at dosing: Males: 225 – 241 g; Females: 208 – 226 g
- Fasting period before study: Feeding was discontinued approx. 16 hours before administration; only tap water was then available ad libitum.
- Housing: During the 14-day observation period the animals will be kept singly in MAKROLON cages (type III plus). Granulated textured wood (Granulat A2, J. Brandenburg, 49424 Goldenstedt, Germany) will be used as bedding material for the cages. The cages will be changed and cleaned twice a week.
- Diet (e.g. ad libitum): ssniff® R/M-H V1534 (ssniff Spezialdiäten GmbH, 59494 Soest, Germany) ad libitum
- Water (e.g. ad libitum): In bottles, ad libitum
- Acclimation period: At least 5 adaptation days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 3°C (maximum range)
- Humidity (%): 55% ± 15% (maximum range)
- Air changes (per hr): Not provided
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: October 29, 2012 To: November 28, 2012

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: On the animal's back between the fore and hind extremities, at least 5 cm x 6 cm.
- % coverage: approx. 1/10 of body surface (10%)
- Type of wrap if used: The test patch was occlusive. The test item was held in contact with the skin with 8 layers of gauze. The gauze was covered with a plastic sheet and secured with adhesive plaster strips on the application site

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 7.46 mL/kg bw
(a correction factor of 3.92 and the density of 1.05 g/mL were applied in order to achieve the dose level of 2000 mg/kg bw)

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Observations were performed before and immediately, 5, 15, 30 and 60 min, as well as 3, 6 and 24 hours after administration. All surviving animals were observed for a period of 14 days.
During the follow-up period (2 weeks) changes in skin and fur, eyes and mucous membranes, and the respiratory, circulatory, autonomic and central nervous system and somatomotor activity and behaviour pattern were observed at least once a day until all symptoms subsided, thereafter each working day. Attention was also paid to possible tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma. Observations on deaths were made at least once daily to minimize loss of animals during the study.
Individual body weights were recorded before administration of the test item and thereafter in weekly intervals up to the end of the study. Changes in weight were calculated and recorded.
The skin was observed for the development of erythema and oedema.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

The LD50 could not be calculated as no animal died prematurely.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

act. ingr.

Mortality:

None of the animals died prematurely.

Clinical signs:

other: No signs of toxicity were observed. No skin reactions were observed at the application site.

Gross pathology:

No signs or abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

According to the EC-Commission directive 67/548/EEC and its subsequent amendments on the approximation of the laws, regulations and administrative provision relating to the classification, packaging and labelling of dangerous substances and the results obtained under the present test conditions, Butanoic acid, 4-amino-4-oxo-2(or 3)-sulfo-, N-(C16-C18 (even numbered), C18 unsaturated alkyl), disodium salts requires no labeling (as LD50 > 2000 mg/kg bw).
Also, according to the EC Regulation 1272/2008 and subsequent regulations, the test material is not classified for acute dermal toxicity.

Executive summary:

In this acute dermal toxicity study, 5 male and 5 female CD rats were applied test item containing 25.5% active ingredient salts for 24 hours under occlusion at a dose level of 2000 mg act. ingr./kg bw and observed for 14 days. The rats revealed no signs of toxicity and no deaths. No skin reactions were observed at the application site. All animals gained the expected body weight throughout the whole experimental period. No signs or abnormalities were noted at necropsy. LD50 > 2000 mg/kg bw.