Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1972
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1972
Report Date:
1972

Materials and methods

Principles of method if other than guideline:
Standard acute method: Test substance at three dose levels was applied to the clipped intact and abraded skin on the back of 12 albino rabbits (4/dose) for 24 hours. Animals were then observed for dermal reactions, food consumption, body weights and general behaviour for 14 days.
GLP compliance:
no
Remarks:
pre-GLP
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Label on test material: RIFM 71-10-56 1-13-72

Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2-3 kg
- Housing: Individually housed in metabolism cages
- Diet (e.g. ad libitum): Rabbit pellets, ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least 2 weeks

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Prior to placing the animals on test their backs were clipped free of all hair with small animal clippers. The backs were further prepared by making epidermal abrasions every two to three centimeters, longitudinally, over the clipped area of exposure. The abrasions were sufficiently deep so that they penetrated the stratum corneum bot not the dermis, so that no bleeding occurred.
- Type of wrap if used: Application areas were covered with a rubber sleeve or dam which fit snuggly around each animal.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Application sites were thoroughly wiped down.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.0, 3.9 and 6.0 mL/kg bw
Duration of exposure:
24 hours
Doses:
2.0, 3.9 and 6.0 mL/kg bw
No. of animals per sex per dose:
4 rabbits/dose
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Examinations performed: During the observation period each animal's food consumption, body weights and general behavior were recorded. Before beginning of the test and at the end of the observation period, haematology and urinalysis were performed on all surviving animals.
- Necropsy of survivors performed: No
Statistics:
None

Results and discussion

Preliminary study:
Not applicable
Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 6 mL/kg bw
Based on:
test mat.
Remarks on result:
no indication of skin irritation up to the relevant limit dose level
Mortality:
No mortality occurred during the study.
Clinical signs:
All animals remained normal throughout the study.
Body weight:
All animals gained normal weight throughout the study.
Gross pathology:
Not applicable
Other findings:
- Dermal reactions: Application sites on the back did not show any erythema or oedema and remained normal throughout the study.
- Food consumption: All animals consumed their daily ration and behaved normal throughout the study.
- Haematology: A comparison of the initial and final haematogram values of each animal did not reveal any significant changes.

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The dermal LD50 of the test substance is > 5000 mg/kg bw in rabbits therefore it is not classified according to Regulation (EC) No 1272/2008 and according to the GHS.
Executive summary:

In an acute dermal toxicity study, 2.0, 3.9 or 6.0 mL/kg bw of the test substance was applied to the clipped intact and abraded skin on the back of 12 albino rabbits (4/dose) for 24 hours. Animals were then observed for dermal reactions, food consumption, body weights and general behaviour for 14 days.

All animals consumed their daily ration, gained weight and behaved as normal laboratory acclimatized animals. Application sites on the back did not show any erythema or oedema and remained normal throughout the study. A comparison of the initial and final haematogram values of each animal did not reveal any significant changes.

Rabbit dermal LD50 > 6 mL/kg bw (equivalent to 5466 mg/kg bw, considering 0.911 g/mL as the density of the test substance).

 

Therefore, the dermal LD50 of the test substance is > 5000 mg/kg bw in rabbits and it is not classified according to Regulation (EC) No 1272/2008 and according to the GHS.