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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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.