1,1,2,3,3,6-hexamethylindan-5-yl methyl ketone

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

Only 7 days observation period, no body weight determination, limited information on effects observed

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

1,1,2,3,3,6-hexamethylindan-5-yl methyl ketone

EC Number:

239-360-0

EC Name:

1,1,2,3,3,6-hexamethylindan-5-yl methyl ketone

Cas Number:

15323-35-0

Molecular formula:

C17H24O

IUPAC Name:

1,1,2,3,3,6-hexamethylindan-5-yl methyl ketone

Test material form:

solid

Specific details on test material used for the study:

- Description: Clear liquid (Super saturated)

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 100 - 160 g
- Fasting period before study: overnight

Administration / exposure

Type of coverage:

not specified

Vehicle:

unchanged (no vehicle)

Doses:

464, 1000, 2150, 4640, 10000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7 days
- Frequency of observations: Observations for mortality and signs of effects were made immediately after dosing at one, four, and 24 hours, and once daily thereafter
- Necropsy of survivors performed: yes

Statistics:

Mortality data was analyzed statistically, utilizing the tables of Horn H.J., Biometrics 12, 311, 1956

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

discriminating dose

Effect level:

10 000 mg/kg bw

Based on:

test mat.

Mortality:

464 mg/kg bw: None
1000 mg/kg bw: One animal died 3 days after treatment
2150 mg/kg bw: None
4640 mg/kg bw: None
10000 mg/kg bw: One animal died 5 days after treatment and another 7 days after treatment.

Clinical signs:

other: 464 mg/kg bw: Within 2 hours of treatment, 3 animals exhibited depression and piloerection, but within 24 hours of treatment all animals appeared normal 1000 mg/kg bw: All animals exhibited depression and piloerection within 2 hours of treatment, 3 of who

Gross pathology:

Within the two lowest dosage groups (464 and 1000 mg/kg bw) and particularly in the 1000 mg/kg bw level, yellow coloration was noted in the intestines. One animal in the 464 mg/kg bw dosage group exhibited this coloration, and 4 in the 1000 mg/kg bw level. All other animals in the study exhibited to notable necropsy findings, except those expected in the normal autolysis of animals found dead.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met