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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:
other: Non-guideline study; use of non-standard vehicle for dosing

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:
- Age at study initiation: 6-7 weeks
- Weight at study initiation: 160 to 200 g (male), 140-180 g (female)
- Fasting period before study:
- Housing: Individually in stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period:


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light):


IN-LIFE DATES: From: To:

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
other: 10% aqueous dispersion of gum Arabic
Details on dermal exposure:
TEST SITE
- Area of exposure: Dorsal zone
- % coverage:
- Type of wrap if used: aluminum foil fastened by a bandaid


REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsed with warm water
- Time after start of exposure: 25 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4 ml/kg
- Concentration (if solution): 50.04 g/100mL
- Constant volume or concentration used: yes
- For solids, paste formed:


VEHICLE
- Amount(s) applied (volume or weight with unit): 4 ml/kg
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:
Duration of exposure:
25 hours
Doses:
0 and 2002 mg/kg
No. of animals per sex per dose:
5 males and 5 females
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 1, 7, and 14 days
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight,organ weights

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 002 mg/kg bw
Mortality:
0 mg/kg: 0/10 dead
2002 mg/kg: 0/10 dead
Clinical signs:
Prostration in one animal. No other behavioral anomalies. Desquamation of the skin noted on test day 11.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
Based on the low level of toxicity and no mortality observed at 2002 mg/kg, material is not classified for acute dermal toxicity.