Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1995
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Analogue substance tested; GLP study using standard method

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: Annex V
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
yellow powder

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River UK
- Age at study initiation: 10 - 14 weeks
- Weight at study initiation: males: 217-253 g; females: 218-246 g

- Housing: individual cages
- Diet (e.g. ad libitum):ad lib.
- Water (e.g. ad libitum): ad lib.
- Acclimation period: > 5 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 -24 C
- Humidity (%): 50-57 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Remarks:
Substance applied as supplied moistened with distilled water.
Details on dermal exposure:
TEST SITE
- Area of exposure: 20 cm²
- % coverage: ca. 10 % of body surface
- Type of wrap if used: surgical gauze + self adhesive bandage + Blenderm(R)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiping with moist cotton
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Constant volume or concentration used: no
- For solids, paste formed: yes (moistened with water)
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: once daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, dermal reactions, body weight, organ weights

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:
Signs of toxicity related to dose levels:
No signs of systemic toxicity were noted.
Body weight:
Males: no effects
Females: 3 of 5 showed a decrease of body weight during week 1 and recovered during week 2. Weight gain was reduced in all females in week 1.
Gross pathology:
No abnormalities were noted at necropsy.
Other findings:
Signs of toxicity (local):
No signs of skin irritation were noted.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
24h of semi-occlusive dermal exposure to an analogue substance did produce slight, transient adverse effects in female rats only. The substance is also not expected to produce severe effects after acute dermal exposure.