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Diss Factsheets

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)
Principles of method if other than guideline:
A single dose of 5000 mg/kg bw was applied to a group of 10 rabbits. Animals were observed for 14 days and necropsied.
GLP compliance:
no
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3-(4-hydroxy-4-methylpentyl)cyclohex-3-ene-1-carbaldehyde; 4-(4-hydroxy-4-methylpentyl)cyclohex-3-ene-1-carbaldehyde
EC Number:
915-617-9
Molecular formula:
C13H22O2
IUPAC Name:
3-(4-hydroxy-4-methylpentyl)cyclohex-3-ene-1-carbaldehyde; 4-(4-hydroxy-4-methylpentyl)cyclohex-3-ene-1-carbaldehyde
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified

Administration / exposure

Type of coverage:
not specified
Vehicle:
not specified
Duration of exposure:
No data
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Statistics:
A statistical analysis was not performed.

Results and discussion

Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
One of the rabbits died on observation day 7 and one on observation day 13. No further mortalities occurred.
Clinical signs:
other: One rabbit which died on day 7 appeared emaciated, lethargic and ptotic and had discharge from nose and eyes on the day prior to death.
Gross pathology:
Necropsy signs of the rabbit which died on day 7 included dried faecal material in the anogenital region, nose and mouth exudate, small spleen, mottled kidneys and red portions of large intestine. The other one showed also mottled kidneys and, in addition, blotchy liver and yellowish nodules on liver.
Other findings:
Skin irritation:
- Redness: slight in 5, moderate in 4, severe in 1.
- Oedema: slight in 2, moderate in 8.

Applicant's summary and conclusion

Interpretation of results:
other: Not harmful
Remarks:
in accordance with EU CLP (EC no 1272/2008 and its amendments)
Conclusions:
An LD50 of > 5000 mg/kg bw was obtained in the acute dermal toxicity study with rabbits.
Executive summary:

In the acute dermal toxicity OECD 402-like study with rabbits (strain unspecified) that pre-dated GLP, a single application of 5000 mg/kg bw of test substance resulted in 2 out of 10 rabbits dying on days 7 and 13 of the observation period. No data on the type of coverage and exposure duration were provided. One rabbit which died on day 7 appeared emaciated, lethargic and ptotic and had discharge from nose and eyes on the day prior to death. Necropsy signs of the rabbit which died on day 7 included dried faecal material in the anogenital region, nose and mouth exudate, small spleen, mottled kidneys and red portions of large intestine. The other one rabbit showed also mottled kidneys and, in addition, blotchy liver and yellowish nodules on liver. Skin irritation signs were observed in all animals: slight erythema was noted in five, moderate in four and severe in one rabbit. Slight oedema was observed in two and moderate oedema was observed in eight rabbits.