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Diss Factsheets

Toxicological information

Repeated dose toxicity: dermal

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Administrative data

Endpoint:
short-term repeated dose toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Analogue substance tested.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 410 (Repeated Dose Dermal Toxicity: 21/28-Day Study)
GLP compliance:
yes
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Analogue substance (refer to IUCLID chapter 13)
IUPAC Name:
Analogue substance (refer to IUCLID chapter 13)

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: 2 % dilution of CMC
Details on exposure:
The test article was applied evenly on the shaved skin and covered with an occlusive dressing. The dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage, for 6 hours per day, 7 days per week for a total of 28 application days.
Duration of treatment / exposure:
Twenty-eight dermal applications were administered to the shaved skin of the back.
Frequency of treatment:
28 application days, 6 hours per day, 7 days per week.
Doses / concentrations
Remarks:
Doses / Concentrations:
1000 mg/kg
Basis:
nominal per unit body weight
No. of animals per sex per dose:
5 males, 5 females
Control animals:
yes, concurrent vehicle

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Dermal irritation:
effects observed, treatment-related
Description (incidence and severity):
focal crust formation and edema
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
no effects observed
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
no effects observed
Haematological findings:
no effects observed
Clinical biochemistry findings:
no effects observed
Urinalysis findings:
no effects observed
Behaviour (functional findings):
not specified
Organ weight findings including organ / body weight ratios:
no effects observed
Gross pathological findings:
no effects observed
Histopathological findings: non-neoplastic:
no effects observed
Histopathological findings: neoplastic:
no effects observed

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

No death occurred during the study.

Applicant's summary and conclusion

Conclusions:
The subacute 28-day repeated dose dermal toxicity study was conducted with the analogue substance. Based on the findings observed in this study the "no-toxic-effect level" of this substance is considered to be > 1000 mg/kg body weight/day for male and female rats. Due to the structural similarity of the analogue substance and the substance subject of registration, the substance subject of registration is expected to show a comparable behaviour.