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Acute Toxicity: dermal
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 November 1998 to 11 January 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- solid: crystalline
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH
- Age at study initiation: 35 - 42 days
- mean body weight at study initiation:
males: 291.8 g +/- 9.8 g, n=5
females: 199.8 g +/- 3.1 g; n=5
- Housing: Altromin Type S8/15, granulated soft wood bedding
- Diet (ad libitum): Altromin 1326, pelleted standard diet, Batch# 150299/1351
- Water (ad libitum): tap water (municipal supply)
- Acclimation period: 13 days before administration
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 22.5 °C
- Humidity (%): 45 - 70%
- Air changes (per hr): air conditioned.
- Photoperiod (hrs dark / hrs light): artificial light was set to give a cycle of 12 our light and 12 hours dark, the light phase was from
6.30 a.m. - 6.30 p.m.
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- water
- Remarks:
- distilled water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 6 x 6 cm (trunk)
- Type of wrap if used: covered with aluminium foil (6.5 x 6.5 cm) which was fixed in place with sticking plaster (Lohmann GmbH & Co, Neuwied)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the application area was washed with water
- Time after start of exposure: 24 hours after application
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.2 g test item/ 100 g body weight. Individual doses were adjusted according to body weight on the day of administration
VEHICLE
- Amount(s) applied (volume or weight with unit): the gauze patch was moistened with distilled water - Duration of exposure:
- 24 h
- Doses:
- Dose group: 2000 mg/kg body weight (b.w.)
0.2 g of the test article per 100 g body weight were applied - No. of animals per sex per dose:
- 5 males per dose
5 females per dose - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for mortality and morbidity continuously on the day of administration and once daily thereafter (in the morning). Animals were also observed for erythema and /or oedema at the skin of the application area one hour after patch removal and once daily thereafter (in the morning). Body weights were recorded on the day of administration and on days 7 and 14.
- Necropsy of survivors performed: At the end of the observation all animals were killed by CO2 inhalation. All animals were examined externally. The cranial, thoracic and abdominal cavities were then opened and examined marcorscopically. - Statistics:
- body weights: calculation of group mean values and standard deviations.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No animal died during the course of investigation.
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:
- Clinical observations: No clinical signs were observed during the course of investigation.
- Body weight:
- The body weight gain of the male and female animals was in the range of the historical control data in the test facility.
- Gross pathology:
- There were no macroscopic pathological findings in the animals.
- Other findings:
- The skin of the application area was not altered.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item is neither a toxic nor a harmful substance according to this acute dermal toxicity study.
- Executive summary:
Acute dermal toxicity of the test item was tested according to OECD Guideline 402 and GLP in five female and five male Cooles River Wistar rats. The test article was applied at a single dose of 2000 mg/kg bw to a shaved dorsal area of the trunk of the animals and was then covered with a gauze patch which was held in contact with the skin with an occlusive dressing. Exposure was for 24 hours. The area to which it was applied was then washed with water. Animals were examined for mortality, clinical signs, alterations of the application area, body weight gain and pathological alterations of organs at the end of a 14-day observation period. None of the animals died during the course of the investigation. Clinical signs, skin alterations on the application area or pathological findings at necropsy were not observed. The body weight gain was not affected.
The dermal LD50 in the rat is > 2000 mg/kg b.w.
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