Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
other: read across from similar substance
Adequacy of study:
key study
Study period:
1981
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards and is described in sufficient detail. Comparable to guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
: 3 instead of 5 animals per dose
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

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: WIGA, Sulzfeld, Germany- Age at study initiation: no data- Weight at study initiation: 233 g (males), 184 g (females)- Housing: no data- Diet (e.g. ad libitum): ad libitum- Water (e.g. ad libitum): ad libitum- Acclimation period: no dataENVIRONMENTAL CONDITIONS: no data

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
TEST SITE- Area of exposure: 50 cm²- Cover: inert plastic filmREMOVAL OF TEST SUBSTANCE- Washing (if done): with tempered water- Time after start of exposure: 24 hTEST MATERIAL- Amount(s) applied (volume or weight with unit): 2000 mg/kg (50% concentration), 1000 mg/kg (50% concentration, 400 mg/kg (50% concentration), 200 mg/kg (25% concentration) and 100 mg/kg (25% concentration)
Duration of exposure:
24 hours
Doses:
2000, 1000 and 400 mg/kg bw (test item concentration: 50% in water); 200 and 100 mg/kg bw (test item concentration: 25% in water)
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days- Investigations: Mortality, clinical signs, local effects- Necropsy performed: yes
Statistics:
N.A.

Results and discussion

Preliminary study:
N.A.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 2 000 mg/kg bw
Based on:
test mat.
Mortality:
see table 1 in section "any other information on results incl. tables"
Clinical signs:
Systemic clinical signs: dyspnea, apathia, excitation, ataxia, spastic gait and poor general condition
Body weight:
N.A.
Gross pathology:
Dead animals: heart: acute hyperemia; stomach organs, fat tissue/musculature: substance-related discolorationSurviving animals: no effects
Other findings:
N.A.

Any other information on results incl. tables

Table 1: Mortality
Dose
(mg/kg bw) 
Concentration
(%)
Animal number found dead within
1 hour 24 hours 48 hours 7 days 14 days
 
2000 50 3m 0/3 0/3 1/3 1/3 1/3
3f 0/3 2/3 2/3 2/3 2/3
1000 50 3m 0/3 0/3 1/3 0/3 0/3
3f 0/3 1/3 1/3 1/3 1/3
400 50 3m 0/3 0/3 0/3 0/3 0/3
3f 0/3 0/3 0/3 0/3 0/3
200 25 3m 0/3 0/3 0/3 0/3 0/3
3f 0/3 1/3 1/3 1/3 1/3
100 25 3m 0/3 0/3 0/3 0/3 0/3
3f 0/3 1/3 1/3 1/3 1/3

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The dermal LD50 in male and female rats is approx. 2000 mg/kg bw based on a product containing 75% of the test item. The corrected LD50 is approx. 1500 mg/kg.
Executive summary:

In an acute dermal toxicity study Sprague Dawley rats (3 males and 3 females per dose group) were dermally exposed to a product containing 75% of the test item in water for 24 hours to 50 cm² of body surface area at 2000, 1000, 400, 200 and 100 mg/kg bw. Animals were observed for a total of 14 days. The animals showed the following systemic clinical signs: dyspnea, apathia, excitation, ataxia, spastic gait and poor general condition. Two females and one male animal of the high dose group died during the observation period. Furthermore, one female animal of the dose groups 100, 200 and 1000 mg/kg bw was found dead within the 14 days. Gross pathology of animals found dead showed an acute hyperemia of the heart and a substance-related discoloration of the stomach, fat tissue and of the musculature. Animals survived the entire observation period showed no treatment related effects at gross pathology observations. Based on the results obtained, the dermal LD50 value of the product in rats was established to be approx. 2000 mg/kg body weight for both sexes. Based on the test item (75%), the corrected LD50 is approx. 1500 mg/kg.