9917 E

Acute Toxicity: dermal

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: Annex V

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Details on test material:

yellow powder

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system 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.