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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to GLP and current guidelines, and is considered relevant, reliable and adequate for classification.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-chloroacetamide
EC Number:
201-174-2
EC Name:
2-chloroacetamide
Cas Number:
79-07-2
Molecular formula:
C2H4ClNO
IUPAC Name:
2-chloroacetamide
Test material form:
solid: crystalline
Details on test material:
- Name of test material (as cited in study report): Chloracetamid, 2-Chloracetamid
- Physical state: White powder
- Analytical purity: > 98%
- Impurities (identity and concentrations): See confidential details
- Composition of test material, percentage of components: See confidential details
- Isomers composition: Not applicable
- Purity test date: 2001-02-27
- Lot/batch No.: DEFC 022450
- Expiration date of the lot/batch: 2002-12-27
- Stability under test conditions: Stable
- Storage condition of test material: Darkness at approximately 20°C in a fume cupboard

Test animals

Species:
rat
Strain:
other: HSD: Sprague Dawley SD (SPF)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: HARLAN WINKELMANN, 33178 Borchen (Germany)
- Age at study initiation: 6-10 weeks
- Weight at study initiation: males 254g (241-267g); females 220g (213-233g)
- Housing: In macrolon cages (type 3) on soft wood granulate, one animals per cage
- Diet: ssniff" R/M-H (V 1534), ad libitum
- Water: tap water in plastic bottles, ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 50 ± 20 %
- Air changes (per hr): fully air-conditioned rooms
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: deionized water
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal skin over an area of approximately 30 cm2
- % coverage: 6 x8 cm
- Type of wrap if used: The appropriate amount of the test substance was moistened on a two-ply gauze and an aluminum foil (6 x 8 cm) and distributed as uniformly as possible. Together with the foil the test substance was administered to the shaved and intact dorsal skin. The foil was held in place with an elastic piaster bandage fixed around the animal's body.

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

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Concentration (if solution): Not provided



Duration of exposure:
24 h
Doses:
2000 mg/kg
No. of animals per sex per dose:
5
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations twice every day (in the morning and in the afternoon), on weekends and public holidays only once; weighing weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred during the whole study.
Clinical signs:
No symptoms were observed after administration of 2000 mg/kg body weight.
The skin of the animals showed no signs of irritation.
Body weight:
Three female animals showed a disturbance of body weight gain during the first week of the study, which
returned to normal until the end of the study. In all other animals development of body weight was not impaired.
Gross pathology:
The animals killed at the end of the observation period showed no macroscopically visible changes.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results obtained in this study the acute dermal LD50 of Chloroacetamide for male and female rats is greater than 2000 mg/kg body weight.
Executive summary:

Acute dermal toxicity of Chloroacetamide was tested in 5 male and 5 female Sprague-Dawley rats at a dose of 2000 mg/kg bw under occlusion. At the end of the dermal exposure period of 24 hours the bandage was removed and the treated skin area washed with warm water in order to remove any unabsorbed remnants of the test substance. The observation period after the dermal administration lasted for 14 days.

No deaths and no symptoms occurred. The skin of the animals showed no signs of irritation. Three female animals showed a disturbance of body weight gain during the first week of the study, which returned to normal until the end of the study. In all other animals development of body weight was not impaired. The animals killed at the end of the observation period showed no macroscopically visible changes.
Based on the results obtained in this study the acute dermal LD50 of Chloroacetamide for male and female rats is greater than 2000 mg/kg body weight.