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EC number: 202-013-9 | CAS number: 90-72-2
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- sub-chronic toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
Data source
Reference
- Reference Type:
- publication
- Title:
- Initial Submission: Final Report - TK 10433 - 28-Days Dermal Toxicity Study in Rats with cover letter dated 080792
- Author:
- unknown
- Year:
- 1 986
- Bibliographic source:
- EPA/OTS Doc # 88-920007287
Materials and methods
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Hardener HY960
- IUPAC Name:
- Hardener HY960
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 4 weeks
- Frequency of treatment:
- 5 days/week
- Control animals:
- yes
Results and discussion
Effect levels
- Dose descriptor:
- NOEL
- Effect level:
- 5 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- other: Local skin effects
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Treatment-related
signs and symptoms included slight to moderate excitability and/or
hypertonicity in the 25 and 125 mg/kg/day dose groups. Slight
to moderate erythema, occasionally accompanied by slight, transient
edema and necrosis, was recorded in the 125 mg/kg/day group. The
irritation disappeared before the end of treatment. Histopathology
revealed moderate to marked hydropic change and slight parakeratosis in
the epidermis in the 125 mg/kg/day dose group. Slight
hydropic changes without obvious parakeratosis was recorded in the 25
mg/kg/day group.
The no-observed effect level (NOEL) was 5 mg/kg/day.
Applicant's summary and conclusion
- Conclusions:
- Tris[dimethylaminomethyl]phenol when applied dermally for four weeks produced localized skin effects and no signs of systemic toxicity at a dose of up to 125 mg/kg/day. The NOEL for effects at the site of administration (skin) was 5 mg/kg/day.
- Executive summary:
The test substance was applied to the skin of rats 5 times a week for 4 weeks at daily doses of 0, 5, 25, or 125 mg/kg. Treatment-related signs and symptoms included slight to moderate excitability and/or hypertonicity in the 25 and 125 mg/kg dose groups. Slight to moderate erythema, occasionally accompanied by slight, transient edema and necrosis, was recorded in the 125 mg/kg group. The irritation disappeared before the end of treatment. Histopathology revealed moderate to marked hydropic change and slight parakeratosis in the epidermis in the 125 mg/kg dose group. Slight hydropic changes without obvious parakeratosis was recorded in the 25 mg/kg group.
The no-observed effect level (NOEL) was 5 mg/kg/day.
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