[No public or meaningful name is available]

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1955

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study is performed with a 35,8% active ingredient formulation, and not under GLP compliance. However, the study is conducted according to state of the art methods at that period. Therefore the study is considered to be adequate, reliable and relevant.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1955

Report date:

1955

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

Observation period of 7 days instead of 14 days

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Aspartic acid, N-(3-carboxy-1-oxo-sulfopropyl)-N-(C16-C18 (even numbered), C18 unsaturated alkyl) tetrasodium salts

EC Number:

939-704-6

Cas Number:

867040-07-1

Molecular formula:

Molecular formula cannot be given as the substance is a mixture

IUPAC Name:

Aspartic acid, N-(3-carboxy-1-oxo-sulfopropyl)-N-(C16-C18 (even numbered), C18 unsaturated alkyl) tetrasodium salts

Test material form:

other: liquid

Test animals

Species:

rabbit

Strain:

other: albino

Sex:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Not provided
- Age at study initiation: Not provided
- Weight at study initiation: Not provided
- Fasting period before study: Not provided
- Housing: Individually
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Not provided

ENVIRONMENTAL CONDITIONS
Not provided

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: abdomen
- % coverage: Not provided
- Type of wrap if used: The material was applied to the closely clipped abdominal skin under rubber damming. The trunks of the animals were wrapped securely with a gauze and adhesive tape binder.

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

TEST MATERIAL
- Concentration (if solution): 35.8%
- Constant volume or concentration used: no

Duration of exposure:

24 hours

Doses:

1.00 mL/kg, 2.15 mL/kg, 4.64 mL/kg and 10 mL/kg

No. of animals per sex per dose:

4

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: Not provided
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs

Results and discussion

Effect levels

Effect levels 1

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 10 mL/kg bw

Based on:

test mat.

Effect levels 2

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 3.5 other: g/kg bw

Based on:

act. ingr.

Remarks:

35%

Mortality:

There were no mortalities at any dosage level tested.

Clinical signs:

other: Throughout the observation period the animals exhibited normal behavior and appearance. A single dermal application produced a mild degree of dermal irritation.

Gross pathology:

At gross autopsy the organs of all animals appeared to be within normal limits.

Other findings:

Not provided

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute dermal LD50 of undiluted test item for albino rabbits is > 10 mL/kg bw, corresponding to > 3500 mg act.ingr./kg bw.

Executive summary:

Groups of four albino rabbits were used to study the dermal toxicity and irritative properties of the test item containing 35.8% act. ingr. following a single application of the undiluted material at dosage levels of 1.00, 2.15, 4.64, or 10 mL/kg of body weight. The material was applied to the closely clipped abdominal skin under rubber damming. The trunks of the animals were wrapped securely with a gauze and adhesive tape binder. After an exposure of 24 hours the binders were removed and the abdomens were sponged with water in order to remove any unabsorbed material. The animals were observed for gross signs of dermal irritation and systemic toxicity for a period of seven days, after which they were sacrificed and gross autopsies performed. There were no mortalities at any dosage level tested. A single dermal application produced a mild degree of dermal irritation. The acute dermal LD₅₀ of undiluted test item for albino rabbits is > 10 mL/kg bw, corresponding to > 3500 mg act.ingr./kg bw.