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Toxicological information

Repeated dose toxicity: dermal

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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:
1986
Bibliographic source:
EPA/OTS Doc # 88-920007287

Materials and methods

GLP compliance:
not specified
Limit test:
no

Test material

Constituent 1
Reference substance name:
Hardener HY960
IUPAC Name:
Hardener HY960

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.