Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented and reported study fully adequate for assessment. The study was conducted according to internationally accepted technical guidelines and in compliance with GLP in a recognized contract research organization.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes (incl. certificate)
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Sprague-Dawley origin (Hsd:Sprague-Dawley (CD))
- Source: Harlan U.K. Ltd., Bicester, Oxon, England.
- Age at study initiation: 8 - 11 weeks
- Weight at study initiation: 221 - 260 g
- Housing: individually in metal cages (RS Biotech Sub-Dividable Rodent Cages - polished stainless steel) until Day 4 when they were returned to group housing. Cages fitted with grid floors.
- Diet (e.g. ad libitum): standard laboratory rodent diet (Special Diet Services RM1(E) SQC expanded pellet)
- Water (e.g. ad libitum): drinking water
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 40 - 70%
- Photoperiod (hrs dark / hrs light): 12h/12h

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: 48% aqueous methycellulose
Details on dermal exposure:
dorso-lumbar region
- Area of exposure: approximately 50 mm x 50 mm
- % coverage: 10
- Type of wrap if used: waterproof dressing (encircled firmly around the trunk of the animal)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water (30-40°C), blotted dry with absorbent paper
- Time after start of exposure: 24h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Concentration (if solution):48% w/v
- Constant volume or concentration used: yes
- For solids, paste formed: yes

VEHICLE
- Amount(s) applied (volume or weight with unit): 4,17 ml
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
10 rats (5 of each sex)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation of clinical signs after dosing, at frequent intervals of this day 1, day 2-14 twice daily,
day 15 in the morning, local dermal irritation daily observed
weighing day 1 (prior to dosing), 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: local dermal irritation (erythema, eschar formation, oedema formation), any other lesion or reaction (spots, scabbing)

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
none
Body weight:
low body weight gain in 1 male and all females on day 8, for 2 females on day 15
Gross pathology:
no abnormalities
Other findings:
dermal reactions: very slight dermal irritation (erythema and/or oedema), resolving completely on day 4. Scabbing and/or spots in 3 females on day 6, resolving completely by day 7, 9, 11.

Applicant's summary and conclusion

Interpretation of results:
other: LD50 > 2000 mg/kg
Conclusions:
No labelling regarding acute dermal toxicity according to Regulation (EC) No 1272/2008 is required.