Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2001
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
adopted February 24, 1987
Deviations:
not specified
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
July 31, 1992
Deviations:
not specified
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: slightly yellow solid
- Analytical purity: unknown
- Lot/batch No.: 766/130
- Expiration date of the lot/batch: 31-AUG-2003
- Stability under test conditions: 4 hours
- Storage condition of test material: at room temperature (range of 20 ± 3 °C), in the dark.

Test animals

Species:
rat
Strain:
other: HanBrl: WIST
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: RCC Ltd, Biotechnology and Animal Breeding Division, Fullinsdorf / Switzerland
- Age at study initiation: Males: 9 weeks, Females: 12 weeks
- Mean weight at study initiation: Females: 204.08 g; Males: 240.16 g
- Fasting period before study: no data.
- Housing: Individually in Makrolon type-3 cages during treatment and observation.
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, batch no. 73/01 (Provimi Kliba AG, Kaiseraugst/ Switzerland), ad libitum.
- Water (e.g. ad libitum): Community tap-water, from Itingen ad libitum.
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
polyethylene glycol
Remarks:
PEG 300
Details on dermal exposure:
TEST SITE
- Area of exposure: backs of the animals (One day before treatment, the backs of the animals were clipped with an electric clipper.)
- % coverage: approximately 10 % of the total body surface
- Type of wrap if used: The semi-occlusive dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The skin was flushed with lukewarm tap water and dried with disposable paper towels.
- Time after start of exposure: Twenty-four hours after the application the dressing was removed.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg body weight
- Concentration (if solution): 0.33 g/ml
- For solids: The test item was weighed into a tared glass beaker on a suitable precision balance and the vehicle added (weight:volume). The mixture was prepared using a glass stick and then a magnetic stirrer.
Homogeneity of the test item in the vehicle was maintained during administration using a magnetic stirrer.
The preparation was made shortly before the dermal application.

VEHICLE
- Amount(s) applied (volume or weight with unit): 6 ml/kg body weight
- Lot/batch no. (if required): 424718/142701
Duration of exposure:
24 h
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 15 days
- Frequency of observations and weighing:
> Mortality / Viability: Daily during acclimatization and twice daily during days 1-15.
> Body weights: On test days 1 (pre-administration), 8 and 15.
> Clinical signs: Daily during acclimatization and at least four times on test day 1 after the test item administration. Once daily during
days 2-15. All abnormalities were recorded.
- Necropsy: At the end of the observation period all animals were sacrificed. The animals were examined macroscopically and all abnormalities recorded. Thereafter, they were discarded.
Statistics:
No statistical analysis was used.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality and no clinical signs were observed.
Mortality:
No deaths occurred during the study.
Clinical signs:
No clinical signs were observed.
Body weight:
The body weight of the animals was within the range commonly recorded for this strain and age.
Gross pathology:
No macroscopic findings were observed at necropsy.
Other findings:
Signs of toxicity (local):
No signs of toxicity were noted.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test material was determined to have an acute dermal LD50 >2000 mg/kg bw (in the rat) under the conditions of the test. The substance is not dermally toxic.
Executive summary:

In this guideline (OECD 402) study conducted with GLP certification, the acute dermal LD50 of the test material (EC 438-340-0) to the rat was determined to be >2000 mg/kg bw (both sexes). The test material was administered under semi-occlusive conditions as a limit test (2000 mg/kg bw) to male and female for 24 hours, with a post application observation period of 15 days. The result of the test does not trigger classification of the test material as acutely toxic according to the EU Classification, Labelling, and Packaging (CLP) regulation (1272/2008).