Registration Dossier

Administrative data

Endpoint:
short-term repeated dose toxicity: dermal
Remarks:
other: 10 dermal applications over a period of 12 to 14 days
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable study report which meets scientific principles but with restrictions (no GLP, no details on experimental procedure).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 410 (Repeated Dose Dermal Toxicity: 21/28-Day Study)
Deviations:
yes
Remarks:
(only 10 applications, no details on test substance, 3 animals/group, one dose level, no control, no data on: animal strain/sex, housing/feeding conditions, duration of application, cover, clinical and cageside examination, food consumption, pathology)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Tinuvin 328S-1 Paste
- Physical state: solid, reddish-brown
- Batch No.: 29/77

Test animals

Species:
rabbit
Strain:
other: albino rabbits
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: adult (estimated from body weight)
- Weight at study initiation: 2.27 kg (mean over all 6 animals)

Administration / exposure

Type of coverage:
not specified
Vehicle:
corn oil
Details on exposure:
TEST SITE
- Area of exposure: 12 x 18 cm
- % coverage: 10

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.8 g of solution in corn oil
- Concentration (if solution): 40% mixture in corn oil
- Constant volume and concentration used: yes
- For solids, paste formed: yes

VEHICLE
- Amount(s) applied (volume or weight with unit): 2 ml
Frequency of treatment:
10 applications (5 per week)
Doses / concentrations
Remarks:
Doses / Concentrations:
140 mg/kg bw
Basis:
other: nominal per unit body weight (value was calculated from concentration and animal body weight data taken from the study)
No. of animals per sex per dose:
3 animals with intact and 3 animals with abraded skin
Control animals:
no

Examinations

Observations and examinations performed and frequency:
CAGE SIDE OBSERVATIONS: No data

DETAILED CLINICAL OBSERVATIONS: No data

DERMAL IRRITATION (if dermal study): Yes

BODY WEIGHT: Yes
- Time schedule for examinations: at start and at the end of the study (after 14 days)

FOOD CONSUMPTION: No data

FOOD EFFICIENCY: No data

WATER CONSUMPTION: No data

OPHTHALMOSCOPIC EXAMINATION: No data

HAEMATOLOGY: No data

CLINICAL CHEMISTRY: No data

URINALYSIS: Yes (there is only data given on the colour)

NEUROBEHAVIOURAL EXAMINATION: No data
Sacrifice and pathology:
GROSS PATHOLOGY: No data
HISTOPATHOLOGY: No data

Results and discussion

Results of examinations

Details on results:
CLINICAL SIGNS AND MORTALITY
Signs of local irritations were noted. The abraded areas healed well. The compound stained the skin and fur orange.

BODY WEIGHT AND WEIGHT GAIN
Gain in body weight was essentially normal in all animals.

URINALYSIS
The urine was brown.

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion