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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable non-GLP study, comparable to guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
not applicable
Qualifier:
equivalent or similar to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: Härter 421 flüssig; Äthanolaminhydrochlorid 45 % (German)
- Physical state: liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: purchased from a breeder (Hagemann)
- Age at study initiation: young adult
- Weight at study initiation (group mean values): 208 g (males), 178 g (females)
- Diet: Herilan MRH-Haltung (H. Eggersmann KG, Germany)

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: back (21 cm²)
- Type of wrap if used: linen

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied: 1000, 4000 mg/kg bw
- Constant concentration used: yes, 100 % (volume was adjusted)
Duration of exposure:
24 hours
Doses:
1000, 4000 mg/kg bw
No. of animals per sex per dose:
3 rats
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical signs were recorded daily (with few exceptions), body weights were recorded after 1, 4, 6, 8, 11 and 13 day(s)
- Necropsy of survivors performed: yes
Statistics:
No statistical analysis was performed.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 4 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths.
Clinical signs:
There were no signs of systemic toxicity.
Transient local signs of slight primary skin irritation were noted after 24 hours. No signs of skin irritation were seen from day 4 until the end of the observation period.
Body weight:
Body weights and body weight development were unaffected by the treatment with the test substance.
Gross pathology:
No macroscopic findings were noted at scheduled necropsy.

Applicant's summary and conclusion