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Toxicological information

Acute Toxicity: dermal

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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:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
- Size of the treatment area not indicated, no information on body weight gain
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Purity: not indicated
The formulation is 50% test substance in 2% CMC (aqueous susp. assumed, but not specifically stated in the report)

Test animals

Species:
rat
Strain:
other: Tif. RAI
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ciba-Geigy breeding unit
- Age at study initiation: not indicated
- Weight at study initiation: 180-200 g
- Housing: individually in Macrolon cages (type 2)
- Diet: ad libitum rat food - NAFAG, Gossau SG
- Water: ad libitum
- Acclimation period: minimum of 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1
- Humidity (%): 55 ± 5
- Air changes (per hr): not indicated
- Photoperiod (hrs dark / hrs light): 10/14

Administration / exposure

Type of coverage:
occlusive
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
2%
Details on dermal exposure:
TEST SITE
- Area of exposure: back
- % coverage: not indicated (shaved area 60 cm2)
- Type of wrap if used: occlusive dressing which was fastened around the trunk with an adhesive elastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with lukewarm water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): not indicated
- Concentration (if solution): 50% formulation
Duration of exposure:
24 hours
Doses:
2150 and 3170 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 3 170 mg/kg bw
Based on:
test mat.
Mortality:
- Number of deaths at each dose: no deaths occurred
- Time of death: not applicable
Clinical signs:
Dyspnoea, exophthalmus, ruffled fur and hunched posture. Animals recovered within 13 days.
Body weight:
Not reported
Gross pathology:
No test substance related gross changes.
Other findings:
SEX-SPECIFIC DIFFERENCES: None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 was determined to be higher than 3170 mg/kg bw