Registration Dossier

Administrative data

Endpoint:
short-term repeated dose toxicity: dermal
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Documentation insufficient for assessment (test substance was applied for only 14 days but twice daily, test substance volume unclear).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Principles of method if other than guideline:
Repeated application (twice daily) of the test substance to mice.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Dehymuls SML, Sorbitanmonolaurat
- Physical state: clear yellow liquid
- Analytical purity: 100%
- Lot/batch No.: LOT 202
- Other information: soluble in mineral oil, dispersible in water

Note: Due to analytical test results the substance is defined as UVCB. For further details see IUCLID Chapter 1.2.

Test animals

Species:
mouse
Strain:
other: HRS hr/hr
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: adult, not further specified

Administration / exposure

Type of coverage:
open
Vehicle:
water
Details on exposure:
TEST SITE
- Area of exposure: back skin, not further specified

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 drops
- Concentration (if solution): 10 and 50%
- Constant volume or concentration used: no

Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
14 days
Frequency of treatment:
twice daily for 5 days per week
Doses / concentrations
Remarks:
Doses / Concentrations:
10 and 50%
Basis:
no data
No. of animals per sex per dose:
5

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Dermal irritation:
no effects observed
Mortality:
no mortality observed
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

Effect levels

Dose descriptor:
NOAEL
Effect level:
50 other: %
Based on:
test mat.
Sex:
female
Basis for effect level:
other: No effects were observed after a repeated application of the test substance as 50% solution (twice daily for 14 days) to the skin of mice.

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion