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:
guideline study without detailed documentation
Remarks:
Guideline study without detailed documentation.

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
-reliability scoring based on 1987 guideline
Deviations:
yes
Remarks:
-Information on purity, source, and physico-chemical properties, acclimatization period not reported; observation period was 7 days; 3/sex/group; insufficient details provided on type of occlusion and exposed skin area; no individual data
GLP compliance:
no
Remarks:
Study pre-dates GLP requirements.
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study report): TK 10352.
- Analytical purity: Not reported.

Test animals

Species:
rat
Strain:
other: Tif.: RAI/f
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Testing facility breeding unit.
- Age at study initiation: 7 to 8 weeks old.
- Weight at study initiation: 180 to 200 g.
- Fasting period before study: Not reported.
- Housing: Housed singly in Macrolon cages (Type 3).
- Diet (e.g. ad libitum): Rat food (NAFAG, Gossau SG), ad libitum.
- Water (e.g. ad libitum): Water, ad libitum.
- Acclimation period: Not reported.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±1.
- Humidity (%): Approximately 50.
- Air changes (per hr): Not reported.
- Photoperiod (hrs dark / hrs light): Not reported.

Administration / exposure

Type of coverage:
not specified
Vehicle:
not specified
Details on dermal exposure:
TEST SITE
- Area of exposure: Rats' back.
- % coverage: Not reported.
- Type of wrap if used: Area was covered with aluminium foil, which was held around the trunk with ISO-ELAST plaster.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Skin was cleaned with warm water to remove all traces of the suspension.
- Time after start of exposure: 24 hours after start of exposure.


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Not reported.
- Concentration (if solution): Not reported.
- Constant volume or concentration used: Not reported.
- For solids, paste formed: Not reported.


VEHICLE
- Amount(s) applied (volume or weight with unit): Not reported.
- Concentration (if solution): Not reported.
- Lot/batch no. (if required): Not reported.
- Purity: Not reported.
Duration of exposure:
24 hours.
Doses:
2150 mg/kg body weight.
No. of animals per sex per dose:
3 per sex.
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days.
- Frequency of observations and weighing: Mortality was observed within 1, 24, and 48 hours and within 7 days.
- Necropsy of survivors performed: Yes.
Statistics:
Not reported.

Results and discussion

Preliminary study:
Not applicable.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 150 mg/kg bw
Remarks on result:
other: None
Mortality:
No mortalities were reported.
Clinical signs:
No symptoms and no local skin irritation were observed.
Body weight:
Not reported.
Gross pathology:
The rats were killed and autopsied after an observation period of 7 days. No substance related gross organ changes were seen in any animals.
Other findings:
No other findings reported.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Information Criteria used for interpretation of results: CLP (EC 1272/2008)
Conclusions:
The acute dermal LD50 of the test substance in rats of both sexes observed over a period of 7 days is >2150 mg/kg body weight. No mortality was observed.
Executive summary:

The compound was tested on 6 Tif,: RAI/f rats (3 males/3 females), bred under SPF conditions. They were 7 to 8 weeks old and weighed 180 to 200 g.

Approximately 6 hours before treatment the rats' backs were shaved with an electric razor. The suspension containing 2150 mg/kg bw (for technical reasons no higher doses were possible) was evenly dispersed on the skin with a Record syringe and covered with aluminium foil, which was held around the trunk with IS0-ELAST plaster. After 24 hours the plaster and the aluminium foil were peeled off carefully and the skin was cleaned with warm water to remove all traces of the suspension.

During treatment and for the 7 day observation period the rats were housed singly in Macrolon cages (Type 3) in a room kept at a constant temperature of 22 ±1 °C and a relative humidity of approximately 50%. They were given water and food ad libitum.

None of the animals died during the entire treatment and observation period. No symptoms and no local skin irritation were observed.

The rats were killed and autopsied after an observation period of 7 days; no substance related gross organ changes were seen.

In conclusion the acute dermal LD50 of the test substance in rats of both sexes observed over a period of 7 days is >2150 mg/kg body weight.