Registration Dossier
Registration Dossier
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EC number: 259-393-4 | CAS number: 54914-37-3
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985-06-11 to 1985-06-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- (1981)
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 1,3,3-trimethyl-N-(2-methylpropylidene)-5-[(2-methylpropylidene)amino]cyclohexanemethylamine
- EC Number:
- 259-393-4
- EC Name:
- 1,3,3-trimethyl-N-(2-methylpropylidene)-5-[(2-methylpropylidene)amino]cyclohexanemethylamine
- Cas Number:
- 54914-37-3
- Molecular formula:
- C18H34N2
- IUPAC Name:
- 1,3,3-Trimethyl-N-(2-methylpropylidene)-5-[(2-methylpropylidene)amino]cyclohexanemethanamine
- Test material form:
- other: liquid
- Details on test material:
- Produced October 1980. Purity 95 %
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Strain: Bor: WISW (SPF TNO)
- Source: F. Winkelmann, Borchen (Germany)
- Weight at study initiation: 5 males mean 229 g, 5 females mean 213 g
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- - Area covered: dorsal skin (shaved 24 hours in advance)
- Occlusion: mull patch, elastic dressing (for 24 hours) - Duration of exposure:
- - Removal of test substance: after patch removal (at 24 hours), thorough washing with warm water and swabbing with cellulose
- Post dose observation period: total duration 14 days - Doses:
- 5000 mg/kg bw (selection based on pre-test performed from 1985-05-21 to 1985-06-12)
- No. of animals per sex per dose:
- 10
- Control animals:
- no
- Details on study design:
- EXAMINATIONS:
- Body weights: before, and 1, 7, 14 days post dosing
- Clinical signs and mortality: within 6 hours after dosing, thereafter daily
- Necropsy: all animals (macroscopic)
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- No deaths
- Clinical signs:
- other: - immediately after treatment: Vehement defense reactions, uttering sounds, both attributed to fixation of patch - at 1 hour: Ruffled fur, stretched posture, temporary uttering sounds, Straub reaction, reddish brown color of application area - after p
- Gross pathology:
- Hyperemia of the small intestinal mucosa and in one animal formation of flecks on the kidneys
Applicant's summary and conclusion
- Conclusions:
- The LD50 value (dermal) of 1,3,3 -Trimethyl-N-(2 -methylpropylidene)-5 -[(2 -methylpropylidene)amino]cyclohexanemethylamine in female and male rats was estimated to be > 5000 mg/kg bw. No mortalities were observed. Therefore, under the conditions employed in this study the substance is of low dermal acute toxicity.
- Executive summary:
1,3,3 -Trimethyl-N-(2 -methylpropylidene)-5 -[(2 -methylpropylidene)amino]cyclohexanemethylamine is of low dermal acute toxicity with a dermal LD50of > 5000 mg/kg bw (OECD 402, Hüls AG, 1985).
For the dermal acute toxicity study no mortalities up to a dose of 5000 mg/kg bw were observed. Clinical signs immediately after treatment were vehement defense reactions, uttering sounds, both attributed to fixation of the patch. At 1 hour the following observations were made: ruffled fur, streched posture, temporary prone position or retarded motion, staggering gait, hypothermia and slight sedation. In the application area necrosis, incrustation of application area, wounds partly with discharge, and formation of scars were observed.
Necropsy findings were Hyperemia of the small intestinal mucosa and in one animal formation of flecks on the kidneys. The body weight was transiently inhibited.
Dermal exposure has to be avoided because of sensitizing properties.
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