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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
Study period:
22 April - 9 July, 1992
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Remarks:
Limited information on the test substance available.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Physical state: liquid
- Storage condition of test material: Room temperature
Specific details on test material used for the study:
- Name as cited in study report: 6398-9-20
- Lot/Batch number: 6398-9-20
- Color: clear
- Storage: during storage no change in physical state of the test article
- specific gravity: 0.948 g/ml

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hazleton Research Products, Denver, PA, USA
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 2233 - 3574 g
- Fasting period before study: no, not applicable
- Housing: individually in cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 30-70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: no data
- % coverage: at least 10% of the body surface was cleared
- Type of wrap if used: rubber dam and an elastic bandage

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

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): control: 5.6-7.3 ml water; 500 mg/kg dose: 1.3-1.9 ml test substance; 2000 mg/kg dose: 5.4-7.5 ml; 3200 mg/kg dose: 9.7-11.4 ml; 4000 mg/kg dose: 9.4-12.2 ml.
- Constant volume or concentration used: no

Duration of exposure:
24 hours
Doses:
0 (water), 500, 2000, 3200, 4000 mg/kg bw
No. of animals per sex per dose:
5 in substance-treated groups and 3 in controls.
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations once daily; body weights at 0h, 7d and 14d after exposure (or when found dead).
- Necropsy of survivors performed: yes
- Other examinations performed: toxicological effects, viability, gross necropsy, histopathology (of control and highest dose group)
Statistics:
Method of Litchfield & Wilcoxon.

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 979.7 mg/kg bw
Based on:
test mat.
95% CL:
>= 993.8 - <= 8 934.1
Sex:
male
Dose descriptor:
LD50
Effect level:
2 979.7 mg/kg bw
Based on:
test mat.
95% CL:
>= 2 037.4 - <= 4 357.9
Sex:
female
Dose descriptor:
LD50
Effect level:
2 979.7 mg/kg bw
Based on:
test mat.
95% CL:
>= 2 037.4 - <= 4 357.9
Mortality:
Control: no mortality
500 mg/kg: no mortality
2000 mg/kg: no mortality
3200 mg/kg: 4/5 females and 4/5 males died during the first 3 days
4000 mg/kg: all animals died within 2 days.
Clinical signs:
Decreased activity, abnormal gait, abnormal stance, dyspnea, body drop, prostration in 2000-3200-4000 mg/kg dose animals.
No clinical signs in control animals and in 500 mg/kg dose animals.
Necrosis of the skin at the application site was observed in all animals exposed to the test substance.
Body weight:
No significant effects compared to controls.
Gross pathology:
Animals that died during the study: discolored thymus and liver, prominent lobular pattern throughout the liver.
Survivors: no relevant effects.
Other findings:
Histopathology: no treatment related effects.

Applicant's summary and conclusion

Interpretation of results:
not classified
Conclusions:
In view of the LD50 value of 2980 mg/kg bw in this rabbit study, the substance does not need to be classified for acute dermal toxicity according to DSD, nor according to CLP.