Isooctyl acetate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

17 October 1983 - 31 October 1983

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 434 (Acute Dermal Toxicity - Fixed Dose Procedure)

Deviations:

yes

Remarks:

during this study several animals were noted to have their collars off. This had no effect on the outcome of the test results.

GLP compliance:

not specified

Test type:

fixed dose procedure

Test material

Test material information

Constituent 1

Reference substance name:

Isooctyl acetate

EC Number:

250-701-2

EC Name:

Isooctyl acetate

Cas Number:

31565-19-2

Molecular formula:

C10H20O2

IUPAC Name:

Acetic acid, isooctyl ester

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Exxon

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: HAZLETON DUTCHLAND INC.
- Age at study initiation: Approx. 17 weeks
- Weight at study initiation: 2.76 - 3.26 kg
- Fasting period before study: Not specified
- Housing: Individual, suspended stainless steel cage with no bedding
- Diet: Purina Rabbit Chow HF (Pellets), ad libitum
- Water: Automatic Watering System, ad libitum. Supplier: Elizabethtown Water Company, Elizabeth, New Jersey.
- Acclimation period: 41 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-21 °C
- Humidity (%): 40-70%
- Photoperiod (hrs dark / hrs light): 12 hr light/dark

IN-LIFE DATES: FROM: 17 Oct 1983 TO: 31 Oct 1983

Administration / exposure

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: The dorsal surface from the shoulder region to the lumbar region
- Type of wrap if used: Gauze patch and secured with tape.

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): 3160 mg/kg/bw

Duration of exposure:

24 hr

Doses:

3160 mg/kg

No. of animals per sex per dose:

3

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 2 and 4 hours after dosing and once per day thereafter, for a total of 14 days.
- Necropsy of survivors performed: Yes.
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other:

Statistics:

Means and standard deviations of the body weights were calculated

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 3 160 mg/kg bw

Mortality:

One animal was noted to sustain a substantial weight loss from the day 0 body weight. Due to this fact this animal was sacrificed on day 11

Clinical signs:

Clinical in-life observation noted during this study included; ocular discharge, poor food consumption and slight emaciation.

Body weight:

One animal was noted to sustain a substantial weight loss from the day 0 body weight. Due to this fact, this animal /as sacrificed on day 11. The surviving 5 animals displayed a slight increase in body weight by study termination.

Gross pathology:

Postmortem gross examination for the animals that was sacrificed on day 11, revealed kidney discoloration, small spleen, small cecum and ilium, brown material in the stomach. The remaining 5 animals showed no observable abnormalities.

Any other information on results incl. tables

Individual dermal irritation scores for all animals are presented in table 1. Supplemental derhal observations are presented in table 2. The survival bar graph is presented in table 3. The incidence of in-life observations is presented in table 4. Individual animal body weights by weighing period, sex, and dose, including the means and standard deviations, are presented in table 5., gross necropsy observations are presented in table 6. The draize hethod of scoring used for evaluation of dermal irritation is presented in appendix a. Appendix b contains individual in-life observations.

 

All of the above are found in the attachment to this rss

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

LD50 > 3160 mg/kg/bw

Executive summary:

The acute dermal irritation potential and systemic toxicity of MRD-83-303 were evaluated in rabbits following topical occlusive exposure. Test material was applied as a single doge of 3160 mg/kg to the clipped backs of 3 male and 3 female rabbits. The test material remained in contact with the intact skin of all animals for a period of 24 hours. After which the skin has washed with distilled water to remove remaining test material, which was estimated to be slight.

 

Observations were made as to the nature, onset, severity; and duration of toxicological signs 2 and 4 hours after dosing and once per day thereafter; for a total of 14 days. Dermal responses were evaluated 24 hours after topical application and on days 3, 7, 10 and 14 according to the draize method of scoring. Body weights were recorded on the day of dosing (day 0, day 7 and day 14, or at death if before day 14. After the day 14 weighings and observat ions, all surviving rabbits were euthanized by intravenous administration of sodium pentobarbital. Gross necropsies were performed on all animals by qualified personnel.

 

One animal was sacrificed on day 11 due to severe weight loss. The surviving 5 animals displayed a slight increase in body weight during the test period.

 

Clinical in-life observations included: food consumption decrease, slight emaciation and ocular discharge.

 

Postmortum gross examination revealed kidney discoloration, small spleen, small cecum and ileum, and brown material in the stomach. These observations were noted in the animal sacrificed on day 11. The remaining animals showed no observable abnormalities.