Acetic acid, C11-14-isoalkyl esters, C13-rich

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

10 July 1979 to 24 July 1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

The test material was applied to abraded skin, under occlusive dressing.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Acetic acid, C11-14-isoalkyl esters, C13-rich

EC Number:

283-740-9

EC Name:

Acetic acid, C11-14-isoalkyl esters, C13-rich

Cas Number:

84712-50-5

Molecular formula:

Not applicable (a generic molecular formula cannot be provided for this specific UVCB substance)

IUPAC Name:

Acetic acid, C11-14-isoalkyl esters, C13-rich

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Expiration date of the lot/batch: no data
- Purity test date: no data

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: no data
- Stability under test conditions: no data


TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: no data
- Preliminary purification step (if any): no data
- Final dilution of a dissolved solid, stock liquid or gel: the test substance was applied undiluted

Test animals

Species:

rabbit

Strain:

other: albino

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no data
- Females (if applicable) nulliparous and non-pregnant: no data
- Age at study initiation: no data
- Weight at study initiation: 2.0 and 3.0 kg
- Fasting period before study: no data
- Housing: no data
- Diet: no data
- Water: no data
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: back (abraded)
- % coverage: no data
- Type of wrap if used: The treated areas were covered with large gauze patches and an impervious material was wrapped snugly around the trunk of each animal.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Any excess material was removed and the approximate amount remaining was noted.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): no data
- Constant volume or concentration used: yes

Duration of exposure:

24 hours

Doses:

2.0 g/kg bw (2000 mg/kg bw)

No. of animals per sex per dose:

3 males and 3 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: the animals were weighed prior to dosing and at the end of the study period.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

Not used

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred throughout the study period.

Clinical signs:

other: No unusual clinical or behavioural signs of toxicity were noted

Gross pathology:

Gross pathologic examinations revealed nothing remarkable.

Other findings:

No other findings were noted.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In the acute dermal toxicity study, conducted according to a protocol similar to OECD TG 402 and in compliance with GLP, the reported LD50 value was greater than 2000 mg/kg bw.