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EC number: 211-776-7 | CAS number: 694-83-7
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1978
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- no weighing was performed; exposed area of the low dosed animals only 4% of the total body surface
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Cyclohex-1,2-ylenediamine
- EC Number:
- 211-776-7
- EC Name:
- Cyclohex-1,2-ylenediamine
- Cas Number:
- 694-83-7
- Molecular formula:
- C6H14N2
- IUPAC Name:
- cyclohexane-1,2-diamine
- Details on test material:
- - Name of test material (as cited in study report): 1,2-Diaminocyclohexan
- Physical state: liquid
- Analytical purity: 98%
- pH: 14
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Wiga, Sulzfeld, D
- Mean weight at study initiation: males 193 g, females 164 g
ENVIRONMENTAL CONDITIONS
not reported
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal and lateral parts of the trunk
- % coverage: 1600-3200 mg/kg bw: ca. 42 cm² -->10% of the total body surface; 1000 mg/kg bw: ca. 12 cm = ca. 4% of the total body surface (considering a mean body weight of 185 g and the formula: body surface area = 10 * (weight (g) *exp 0.67))
- Type of wrap if used: aluminium foil
REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm water and water/Lutrol - Duration of exposure:
- 24 h
- Doses:
- 1000, 1600, 2000, 2500 and 3200 mg/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: observations: several times on the day of administration and at least once each workday; check for moribund and dead animals twice each workday and once on holidays; weighing after day 0 was not reported
- Necropsy of survivors performed: yes - Statistics:
- Probit analysis
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 1 870 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 1 700 - 2 050
- Remarks on result:
- other: LD50 for males: not calculated; LD50 for females: 1786 mg/kg bw
- Mortality:
- 1000 mg/kg bw: 0 males and 0 females died
1600 mg/kg bw: 0 males and 1 females died within 24 hours
2000 mg/kg bw: 3 males and 4 females died; thereof, 5 animals died within 48 hours
2500 mg/kg bw: all animals died within 48 hours
3200 mg/kg bw: all animals died within 24 hours - Clinical signs:
- other: other: screaming directly after application, high-stepping gait on the day of administration (>= 1600 mg/kg bw), strong apathy (not reversible at the 1600 mg/kg bw treatment, reversible within 6 days at the 1000 mg/kg bw treatment)
- Gross pathology:
- Animals that died: (right) heart dilatation, congestion hyperemia, pale liver and kidneys
Surviving animals: nothing abnormal observed - Other findings:
- 24 hours after application, animals showed formation of necrosis; within the observation period, open and moisted necrosis were observed (local concentration ranged from ca. 38 to 77 mg test substance/cm² skin for the 1600-3200 mg/kg bw treatment and ca. 83 mg/ cm² skin for the 1000 mg/kg bw treatment due to the smaller exposure area of this treatment)
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- Under the applied test condition the test substance has an LD50 value of 1870 mg/kg bw.
- Executive summary:
In a study similar to OECD guideline 402, test substance was administered under occlusive conditions for 24 h to the skin of 5 male and 5 female Sprague-Dawley rats per dose group (1000, 1600, 2000, 2500 and 3200 mg/kg bw) . The LD 50 value was calculated to be 1870 mg/kg bw.
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