Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
October 1995- January 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted under GLP using OECD guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

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 (incl. certificate)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
F-3014
Batch number 016
Date received 2 October 1995
Description white solid
Storage temperature room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles river (UK) Ltd
- Age at study initiation: 10-14 weeks
- Weight at study initiation: males 242-256 gr; females 200-206 gr
-acclimatisation: 5 days
- Housing: animals were housed in groups of up to five by sex in solid-floor polypropylene cages furnished with woodflakes.
- Diet (e.g. ad libitum): mouse and rat No 1 special diets services Limited WithamEssex (UK) was allowed during the study
- Water (e.g. ad libitum): mains drinking water.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 45-54
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12-12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
arachis oil
Details on dermal exposure:
TEST SITE
- Area of exposure: specific area not mentioned
- % coverage: approx. 10% of the total body surface area
- Type of wrap if used: A piece of surgical gauze was placed over the treatment are and semi-occluded with a piece of BLENDERM wrapped around each end.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: 24 hr

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg
- For solids, paste formed: yes

Duration of exposure:
24 hr
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 0.5, 1, 2 and 4 hr after dosing and subsequently once daily for 14 days (observation regarding death or overt signs of toxicity) .
- Frequency of observations and weighing: Once daily
- Necropsy of survivors performed: yes/no
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: gross pathological examination has been done

Results and discussion

Preliminary study:
not conducted
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
no deaths
Clinical signs:
no signs of systemic toxicity
Body weight:
increase
Gross pathology:
no abnormalities

Any other information on results incl. tables

see attached file (tables plus results)

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information non toxic Criteria used for interpretation of results: EU
Conclusions:
The acute dermal median lethal dose (LD50) of the test material, F-3014 in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight.
No symbol and risk phrase are required according to EU labelling regulations.
Executive summary:

The acute dermal median lethal dose (LD50) of the test material, F-3014 in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight.

No symbol and risk phrase are required according to EU labelling regulations.