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EC number: - | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
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- Particle size distribution (Granulometry)
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![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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:
- 2004-06-02 to 2004-06-24
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: CD, Crl. CD
- Sex:
- male/female
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 5 x 6 cm, approx 10 % of body surface
- % coverage: no data
- Type of wrap if used: The test item suspension was applied to 8 layers of gauze. The gauze was covered with a plastic sheet and secured with
adhesive plaster on the application site.
The test substance was administrated dermal, on the shaved intact dorsal skin.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the exposure period no residual test item had to be removed
TEST MATERIAL
The test substance was suspended in aqua ad injectabilia
Administrated volume: 10 mL/kg bw
Dose level: 2000 mg/kg bw
VEHICLE
aqua ad injectabilia - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 male and 5 female
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were performed before and immediately, 5, 15, 30 and 60 min, as well as 3, 6 and 24 hrs
after administration, thereafter at least once daily.
Individual body weights were recorded before administration of the test substance and thereafter in weekly intervals up to the end of the study.
During the follow-up period, changes of skin and fur, eyes and mucous membranes, respiratory and circulatory function, autonomic and central
nervous system and somatomotor activity as well as behavior pattern were observed at least once a day until all symptoms subsided, thereafter
each working day. Attention was also paid to possible tremors, convulsions, salivation, diarrhea, lethargy, sleep and coma.
- Necropsy of survivors performed: All surviving animals were sacrificed, dissected and inspected macroscopically. All gross pathological changes
were recorded. No histopathology was carried out as no macroscopic findings were noted at necropsy.
other: skin irritation was scored according to the Draize scheme. - Statistics:
- N/A
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- no animal died
- Clinical signs:
- other: no signs of toxicity were observed
- Gross pathology:
- No marcroscopical changes were noted at necropsy.
- Other findings:
- No erythema or oedema were observed. All readings were 0.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- On the basis of the results obtained after a single dermal administration, the dermal LD50 of the test article "partially unsaturated TEA-Esterquat" was determined to be > 2000 mg/kg bw. No animal died. No clinical signs or gross pathological findings were observed. Normal weight gain was observed, except for one female rat. Its body weight gain appeared to be slightly reduced.
- Executive summary:
In an acute dermal toxicity study according to OECD guideline 402, 1987 and EU method B.3, 1992, 5 male and 5 female young adult CD rats were dermally exposed to the partially unsaturated TEA-Esterquat suspended in water for 24 hours under an occlusive dressing to approx. 10 % of body surface area at doses of 2000 mg/kg bw. Animals then were observed for14 days.
Dermal LD50 Males > 2000 mg/kg bw
Females > 2000 mg/kg bw
Combined > 2000 mg/kg bw
No mortality occurred in this limit test.
No clinical signs were observed. No macroscopical changes were noted at gross pathological examinations at terminal necropsy.
Normal weight gain was observed, except for one female rat. Its body weight gain appeared to be slightly reduced.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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