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Toxicological information

Repeated dose toxicity: dermal

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Administrative data

Endpoint:
repeated dose toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Read across to related substance with same EC number (410-190-0) identified during Inquiry Process (Inquiry number: 06-0000021779-56-0000). Previous data (>12 yrs old) provided by ECHA.

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Annex V
Deviations:
not specified
GLP compliance:
yes
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Type of coverage:
not specified
Vehicle:
not specified
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
Test Duration: 28 days
Frequency of treatment:
Dosing regime: 5 days / week
No. of animals per sex per dose:
Male: 10 animals at 0 mg/kg bw/day
Male: 10 animals at 125 mg/kg bw/day
Male: 10 animals at 500 mg/kg bw/day
Male: 10 animals at 2000 mg/kg bw/day
Female: 10 animals at 0 mg/kg bw/day
Female: 10 animals at 125 mg/kg bw/day
Female: 10 animals at 500 mg/kg bw/day
Female: 10 animals at 2000 mg/kg bw/day
Control animals:
yes, concurrent vehicle

Results and discussion

Results of examinations

Clinical signs:
not examined
Dermal irritation:
not specified
Mortality:
not examined
Body weight and weight changes:
not specified
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
not specified
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
not specified
Histopathological findings: non-neoplastic:
not specified
Histopathological findings: neoplastic:
not specified
Details on results:
Clinical observations:
No deaths and no signs of toxicity were observed.
Laboratory findings:
A slightly increased (33%) level of aspartate aminotransferase was seen in the 2000mg/kg treated females after four weeks.

Effects in organs:
Minimal epidermal hyperplasia was observed in females treated at 500 and 2000mg/kg.

Minor adrenal vacuolation was noted in 3 males at 2000mg/kg.

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
500 mg/kg bw/day
Basis for effect level:
other: original NCD unit is mg/kg/day
Dose descriptor:
NOEL
Effect level:
125 mg/kg bw/day
Basis for effect level:
other: original NCD unit is mg/kg/day

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Not classified for repeat dose dermal toxicity; the NOAEL was set to 500 mg/kg bw/d in this subacute dermal toxicity study.