Registration Dossier

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:
other: The test was conducted similarly to OECD test guideline No. 402 with minor deviations: occlusive dressing, number of animal tested is not standard, no details on test animals and conditions, no data on gross pathology.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1971
Report Date:
1971

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
occlusive dressing, number of animal tested is not standard, no details on test animals and conditions, no data on gross pathology
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): CFI-A alpha-Hexyl Cinnamate Aldehyde

Test animals

Species:
rabbit
Strain:
other: albino
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: no data
- Fasting period before study: no data
- Housing: in cages
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): 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: 12 cm wide and covering the entire circumference of the rabbits
- % coverage:
- Type of wrap if used: rubber sheeting and the ends taped to the rabbits


REMOVAL OF TEST SUBSTANCE
- Washing (if done): no details given
- Time after start of exposure: 24 h
Duration of exposure:
The animals were exposed during 24 h
Doses:
One animal was treated at 1000 mg/kg bw, one animal at 2000 mg/kg bw level and three animals were treated at 3000 mg/kg bw
No. of animals per sex per dose:
A total of 5 female albino rabbits were treated.
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: after 24h of tretament, the rubber sheets were removed and the animals were observed during 7 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: no
- Other examinations performed: only observation was done

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 3 000 mg/kg bw
Remarks on result:
other: no animals died at this dose
Mortality:
No animals died

Any other information on results incl. tables

Moderate erythema was seen with all compounds. Occassional sloughing was seen but this was in large part due to damage caused by the removal of the tape from the skin and is not believed to be drug related. All rabbits appeared normal by the end of the test period.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Dermal LD50Combined > 3000 mg/kg bw
Executive summary:

In an acute dermal toxicity study female albino rabbits were exposed to undiluted Hexyl cinnamic aldehyde (HCA) for 24 hours (area exposure of 12 cm) at doses of 1000 (1 animal), 2000 (1 animal) or 3000 (3 animals) mg/kg bw under an occlusive coverage. Animals then were observed for 7 days.

 

Dermal LD50 Combined > 3000 mg/kg bw

 

No animals died at any dose level tested. Moderate erythema was seen with all compounds. All rabbits appeared normal by the end of the test period

 

Under the test conditions, HCA is not classified according to the Directive 67/548/EEC and Regulation (EC) No. 1272/2008.

This study is considered as acceptable and satisfies the guideline requirement for an acute dermal toxicity study.