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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
22 May 2012 to 27 June 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Details on test material:
- Physical state: solid
- Appearance: black
- Storage condition of test material: room temperature in the dark in sealed bags

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Age at study initiation: 8 - 10 weeks (males); 12 - 14 weeks (females)
- Weight at study initiation: 240 - 262 g (amles); 206-223 g (females)
- Fasting period before study: no data
- Housing: animals were individually housed in IVC cages, type III H furnished with Altromin saw fibre bedding
- Diet: ALTROMIN 1324 maintenance diet for rats and mice (ad libitum)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 55 ± 10 %
- Air changes (per hr): 10 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Vehicle:
TEST SITE
- Area of exposure: back
- % coverage: ca 10 % of body surface
- Type of wrap if used: semiocclusive gauze + adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with water
- Time after start of exposure: at end of exposure

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg
- Concentration (if solution): 100 %
- Constant volume or concentration used: yes
- For solids, paste formed: no, the test material was used as supplied. In order to ensure good skin contact it was moistened with aqua ad injectionem.
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were weighed on days 1 (prior to application), 8 and 15. A clinical examination was made several time of the day of dosing; thereafter, animals were observed daily.
- Necropsy of survivors performed: yes, macroscopic

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Mortality:
None of the animals died during the study.
Clinical signs:
No signs of toxicity were noted during the study.
Body weight:
The body weight development of all male and female animals was within the expected range.
Gross pathology:
Male 21 had a yellow spot on the epididymides. Male 22 had granulated Peyer' patches. these were considered incidental findings and were not considered to be related to treatment with the test material. No specific gross pathological changes were recorded for any other animals.
Other findings:
No erythema or oedema was noted on any animal during the study.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the study the acute dermal LD50 of the test material was determined to be in excess of 2000 mg/kg bw.
Executive summary:

The acute dermal toxicity of the test material was investigated in a study which was conducted under GLP conditions and in accordance with the standardised guidelines OECD 402, EU Method B.3 and EPA OPPTS 870.1200.

During the study, five male and five female rats received semi-occlusive dermal applications of 2000 mg/kg bw of test material. The exposure duration was 24 hours. The animals were observed for mortality, clinical signs, body weight changes and local reactions for 14 days after which time they were sacrificed and subjected to gross necropsy.

Under the conditions of the study, none of the animals died, no clinical signs were observed and the body weight development of all male and female animals was within the expected range. Male 21 had a yellow spot on the epididymides. Male 22 had granulated Peyer' patches. These were considered incidental findings and were not considered to be related to treatment with the test material. No specific gross pathological changes were recorded for any other animals. No erythema or oedema was noted on any animal during the study.

It was therefore concluded that the acute dermal LD50 of the test material is in excess of 2000 mg/kg bw.

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