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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2003-09-03 - 2003-11-21
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD TG 402) performed under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2003

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
adopted on 24th February 1987
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
adopted on 31st July 1992
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Test material form:
solid: bulk
Details on test material:
Please refer to "Confidential details on test material".

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: approximately 8 weeks old
- Body weight at study initiation: 309 ± 5 g (males), 231 ± 5 g (females)
- Housing: animals were housed individually in polycarbonate cages with stainless steel lid (35.5 cm x 23.5 cm x 19.3 cm), each cage contained autoclaved sawdust (SICSA, Alfortville, France).
- Diet: A04 C pelleted diet (SAFE, Villemoisson, Epinay-sur-Orge, France), ad libitum
- Water: Drinking water filtered by a FG Millipore membrane (0.22 micron), ad libitum
- Acclimation period: at least 5 days before the beginning of the study

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Humidity: 30 - 70%
- Air changes: approximately 12 air changes/hour
- Photoperiod: 12 h / 12 h

IN-LIFE DATES: From: 2003-09-17 To: 2003-10-01

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal area of each animal was clipped (males: appr. 5 x 7 cm; females: appr. 5 x 6 cm)
- Coverage: Approximately 10 % of the total body surface
- On test day 1 a single dose of 2000 mg/kg bw of the test item was placed on a hydrophilic gauze pad (pre-moistened with 2 mL of purified water) and then applied on the intact skin with an aerated semi-occlusive dressing
- Type of wrap: Restraining bandage, this dressing prevented ingestion of the test item by the animal

REMOVAL OF TEST SUBSTANCE
- Washing: Any residual test item was removed using a moistened cotton pad
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount applied: 2000 mg/kg bw
- Constant volume

VEHICLE
- Amount applied: 2 mL per rat
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 rats
Control animals:
other: not applicable
Details on study design:
- Duration of observation period following administration: 14 days

- Mortality/Viability and frequency of observations (clinical signs): The animals were observed frequently during the hours following administration of the test item, for detection of possible treatment-related clinical signs. Thereafter, observation of the animals was made at least once a day until termination. Type, time of onset and duration of clinical signs were recorded for each animal individually.

- Frequency of weighing: The animals were weighed individually just before administration of the test item on day 1 and then on days 8 and 15. The body weight gain of the treated animals was compared to that of CIT control animals with a similar initial body weight.

- Necropsy of survivors performed: At the end of the observation period, all animals were killed by carbon dioxide asphyxiation and examined macroscopically. All study animals were subjected to a macroscopic examination as soon as possible after death. After opening the thoracic and abdominal cavities, a macroscopic examination of the main organs (digestive tract, heart, kidneys, liver, lungs, pancreas, spleen and any other organs with obvious abnormalities) was performed. No organ samples were taken.
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.
Mortality:
No mortality was observed at 2000 mg/kg bw.
Clinical signs:
other: Signs of toxicity related to dose levels: None. A white coloration of the skin was noted in all animals on day 2.
Gross pathology:
Macroscopic examination of the main organs of the animals revealed no apparent abnormalities
Other findings:
Signs of toxicity (local): None.

Applicant's summary and conclusion