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EC number: 201-174-2 | CAS number: 79-07-2
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- sub-chronic toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study was done with a formulation having a different composition (70% Chloroacetamide; 30% sodium benzoate), however it was considered reliable, adequate and relevant for classification and local DNEL calculation. As there is no clinical biochemistry and only limited histopathology, the study cannot be used for systemic DNELs.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 971
- Report date:
- 1971
Materials and methods
- Principles of method if other than guideline:
- IBR guideline
- GLP compliance:
- no
- Limit test:
- yes
Test material
- 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): Konservierungsmittel CA 24; CA 24
- Physical state: White, fine crystalline powder
- Composition of test material, percentage of components: Technical mixture: 70% chloroacetamide, 30% sodium benzoate DAB 7
- Other: Firma Biochema Schaben, Memmingen
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Wistar SPF
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Paderborn
- Age at study initiation: Adult
- Weight at study initiation: Average ca. 210 g
- Housing: Individual cages
- Diet: Rattenstandardiät (ssniff/Intermast), ad libitum
- Water: Ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1°C
- Humidity (%):45-55%
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- open
- Vehicle:
- water
- Details on exposure:
- The test substance was dissolved in water, pure or supplied with 1-2 % Lanette R.
Back of animals had been partly shorn.
Using a glass rod, the test solution was applied daily onto the shorn areas. - Duration of treatment / exposure:
- 3 months / 13 weeks
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 12.5, 50.0 mg/kg
Basis:
nominal per unit body weight
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- Control: Lanette; Group I, 12.5 mg/kg in Lanette 1 %; Group II, 50.0 mg/kg in Lanette 2 %; Group III, 50.0 mg/kg in aqua dest 2 %;
Examinations
- Observations and examinations performed and frequency:
- clinical symptoms : daily
body weight, weight gains, feed use, feed efficiency, water used : weekly - Sacrifice and pathology:
- section: weights of heart, liver, kidneys, adrenal glands, testicles
histology: testicles
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 50 mg/kg bw/day (nominal)
- Sex:
- male
- Basis for effect level:
- other: clinical signs; mortality; body weight; food consumption; gross pathology; organ weights; histopathology
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The dermal “no-effect” level of CA 24 in male adult rats is 50 mg/kg bw.
- Executive summary:
In a 13 weeks dermal toxicity repeated dose study, Konservierungsmittel CA 24 was applied to the shaved backs of male adult Wistar-rats, at doses of 12.5 and 50.0 mg/kg in Lanette or Aqua dest. Neither test dependent or substance specific changes were observed in the growth parameters and histomorphological examinations. The dermal “no-effect” level of CA 24 in male adult rats is 50 mg/kg bw.
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