Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
10 September to 16 October 1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study in accordance with internationally recognised guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): ADK STAB PEP-36
- Physical state: Solid, white powder
- Purity: >99%
- Lot/batch No.: L-10181
- Expiration date of the lot/batch: 1 August 1992
- Storage condition of test material: In the original container; protected from light at room temperature (approx. 20°C)

Test animals

Species:
rat
Strain:
other: HanIbm: WIST (SPF)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: a biological research laboratory
- Age at study initiation: 10 weeks (males); 12 weeks (females)
- Weight at study initiation: 231-244 g (males); 198-214 g (females)
- Fasting period before study: no
- Housing: individually in Makrolon type-2 cages (size: 16.5 x 22 x 14 cm) with standard softwood bedding.
- Diet: pelleted standard rat maintenance diet, ad libitum.
- Water: community tap water, ad libitum.
- 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 hours light/12 hour dark

IN-LIFE DATES: From: To: 17 September to 1 October 1991

Administration / exposure

Type of coverage:
occlusive
Vehicle:
polyethylene glycol
Details on dermal exposure:
TEST SITE
- Area of exposure: the back of the animal
- % coverage: 10
- Type of wrap if used: semi-occlusive dressing fixed with an elastic adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): 24 hrs after application the dressing was removed and the skin washed with lukewarm water and dried with disposable paper towel.
- Time after start of exposure: approximately 24 hours

TEST MATERIAL
- Amount(s) applied (weight): 2000mg/kg

VEHICLE
- Amount(s) applied (volume): 4ml
Duration of exposure:
24 h
Doses:
2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 15 days
- Frequency of observations and weighing:
Mortality: four times during test day 1, and daily during days 2 to15.
Body weight: day 1 (pre-administration), 8 and 15.
Clinical signs: each animal was examined for changes in appearance and behaviour four times during day 1, and daily during days 2 to 1 5. All abnormalities were recorded. Due to the 24 hour semi-occlusive treatment, the local findings were observed starting with day 2
of the test.

- Necropsy of survivors performed: yes
Statistics:
Not applicable to a limit test.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
No signs of toxicity were observed during the test (0/10).
Body weight:
The body weight gain of the animals was not affected throughout the study by test article treatment.
Gross pathology:
No macroscopic abnormalities were observed at the end of the study.
Other findings:
No skin irritation was observed during the test.

Any other information on results incl. tables

No mortality occurred during 15 days of observation.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
As no mortality occurred during 15 days of observation, the toxicity of ADK STAB PEP-36 was estimated to be greater than 2000 mg/kg.