Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study conducted according to GLP. However, purity of test article is unknown.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
(1981)
Deviations:
yes
Remarks:
Semi-occlusive dressing is recommended by guideline. However, occlusive dressing was used (worst case).
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Details on test material:
- Physical state: solid
- Analytical purity: commercial grade
- Lot/batch No.: Op. 11006
- Expiration date of the lot/batch: 1995-12-31
- Stability of test article: stable
- Stability under test conditions: stable for at least 2 h.

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
-Strain as stated in the report: KFM-Han. Wistar (outbred, SPF)
- Source: Kleintierfarm Madoerin AG CH-4414 Fuellinsdorf / Switzerland
- Age at study initiation: 9 - 11 weeks
- Weight at study initiation: 228 - 256 g (males), 197 - 211 g (females)
- Housing: individually in Makrolon type-2 cages
- Diet (ad libitum): pelleted standar Kliba 343, rat maintenance diet
- Water (ad libitum): tap water
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 40 - 70
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Type of coverage:
occlusive
Vehicle:
polyethylene glycol
Remarks:
PEG 400
Details on dermal exposure:
TEST SITE
- Area of exposure: back of animals
- % coverage: 10 % of total body surface
- Type of wrap: Occlusive dressing fixed with elastic adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing: Skin was washed with lukewarm tap water
- Time after start of exposure: 24 h

TEST MATERIAL
- Application Volume/kg bw: 4 ml, corresponding to 2000 mg/kg bw.
- For solids, paste formed: Yes, test article was homogenised in PEG 400.
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
10 animals (5 males, 5 females)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 15 days
- Frequency of observations for mortality and clinical symptoms: 4-times at day one, afterwards daily.
- Frequency of weighing: Weights of animals were assessed on day 1, 8 and 15.
- Necropsy of survivors performed: Yes, all animals were sacrificed and subjected to gross pathology.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: None of the treated animals died.
Mortality:
No animal died.
Clinical signs:
After treatment a reddish skin discoloration was observed in all rats during the observation period. No other signs of local or systemic toxicity were observed.
Body weight:
Body weight of animals increased during study period (mean values see below).
Gross pathology:
No macroscopic findings were observed at necropsy.

Any other information on results incl. tables

Table 1: Mean body weights in grams (Dose level: 2000 mg/kg bw)

Test day

1*

8

15

 

 

 

 

Male

240 +/- 10

255 +/- 11

275 +/- 14

Female

206 +/- 5.4

211 +/- 8

219 +/- 8.7

body weights on day 1 were assessed before application of 2000 mg/kg bw.

Applicant's summary and conclusion