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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report in general agreement with OECD guideline 402. GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
occlusive dressing used
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: low viscosity liquid hydrocarbon

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Alpine Laboratory Rabbits
- Age at study initiation: Young adult
- Weight at study initiation: 1.9-2.40 kg at time of dosing
- Housing: Individually
- Diet (e.g. ad libitum): Purina rabbit chow, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 68 - 74 °F
- Humidity (%): 31 - 70% relative humidity
- Photoperiod (hrs dark / hrs light): 12/12 hour, light/dark cycle

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
The application site was covered with a 4" square gauze pad which was stabilized with a strip of hypoallergenic tape, after which a dental dam was applied around the back and abdomen and secured in place with a 3" packaging tape. After 24 hours, the wrapping was removed and the skin wiped to remove any test substance still remaining.
Duration of exposure:
24 hrs
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 male and 5 female
Control animals:
no
Details on study design:
One application site, approximately 4" square, on the back was selected. The test site was abraded in all rabbits using a sterile 20 guage needle just penetrating the stratum corneum and not the dermis.

The application site was covered with a 4" square gauze pad which was stabilized with a strip of hypoallergenic tape, after which a dental dam was applied around the back and abdomen and secured in place with a 3" packaging tape. After 24 hours, the wrapping was removed and the skin wiped to remove any test substance still remaining.

The test animals were observed for 14 -days after dosing. The animals were observed at hourly intervals for the first 4 hours after dosing. Thereafter, observations were made twice daily for the duration of the study. Observations included: oral discharge, nasal discharge, respiration, tremors, incoordination, recumbancy and stools.

At the end of the 14 days, all surviving animals were sacrificed with CO2. All test animals at dying were submitted to gross necropsy. Gross necropsy was performed under supervision of the study director. The gross necropsy included the observation of salivary glands, thymus, trachea, esophagus, cervical lymph nodes, heart, aorta, kidney, urinary bladder,skeletal muscle, skin, lungs, thyroid glands, adrenal glands, gall bladder, stomach, duodenum, jejunum, ileum, cecum, colon, rectum, pancreas, spleen, testes or ovaries, and liver.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
All ten animals survived to termination of the study.
Clinical signs:
Dermal irritation that lasted till termination of the study.
Body weight:
Body weight did not appear to be affected.
Gross pathology:
No visible lesions, with the exception of the dermal effects.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 for F-64-01 is >2000 mg/kg.  Based on these findings, F-64-01 does not warrant classification as an acute dermal toxicant under Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
Executive summary:

The acute toxicity of F-64-01 was evaluated in rabbits via occlusive dermal application at 2000 mg/kg body weight. Observations were made hourly for the first 4 hours immediately after dosing and twice daily (a.m. and p.m.) for the next 14 days.  No animals died during the observational period.   The surviving animals displayed little or no abnormalities. The surviving animals had no observable abnormalities. The LD50 for F-64-01 is >2000 mg/kg.  Based on these findings, F-64-01 does not warrant classification as an acute dermal toxicant under Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.