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:
other: 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
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 truck 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:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP (EC 1272/2008)