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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:
supporting 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:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: EPA 40 CFR, Par. 158.50 & 158.135, Subdivision F, Section 81-2, pp. 39 - 44, Nov. 1982
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid - liquid: aqueous solution

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: at least 2-3 kg
- Diet (e.g. ad libitum): rabbit diet, ad libitum
- Water (e.g. ad libitum): ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature: 65-75°F
- Humidity (%): 40-60%
- 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: dorso-laterally from.the pectoral to the pelvic areas

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 g/ kg bw

Duration of exposure:
24 h
Doses:
2 g/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: twice daily (clinical signs), once a week (weighing), after 24 and 72 h (irritation)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, skin irritation:

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 450 mg/kg bw
Based on:
act. ingr.
Mortality:
2 females died.
Clinical signs:
depression, diarrhea, laboured breathing
Body weight:
5/8 surviving animals showed weight loss on day 14.
Other findings:
The test item was corrosive.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
Dermal LD50 Combined > 2000 mg test material/kg bw
Dermal LD50 Combined > 450 mg a.i./kg bw
Executive summary:

In an acute dermal toxicity study according to EPA 40 CFR, Par. 158.50 & 158.135, Subdivision F, Section 81-2, New Zealand White rabbits (5/sex) were dermally exposed to Reaction product of lauryl-PDA/lauryl-DETA with chloroacetic acid (22.5% a.i) for 24 hours at a single dose of 2000 mg/kg bw in terms of test material (corresponding to 450 mg a.i./kg bw). Animals then were observed for 14 days.

2/5 females died during the observation period. 5/8 surviving animals showed weight loss on day 14.

The test item was corrosive to the skin (edema and erythema scores of 4 after 24 and 48 h). The skin sites were severely burned and discoloured black. The skin was thickened and stiff.

 

Dermal LD50 Combined > 2000 mg test material/kg bw

Dermal LD50 Combined > 450 mg a.i./kg bw