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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
12 June 2012 - 16 July 2012
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Compliant to GLP and testing guidelines; adequate consistence between data, comments and conclusions.

Data source

Reference Type:
study report

Materials and methods

Test guidelineopen allclose all
according to guideline
OECD Guideline 402 (Acute Dermal Toxicity)
according to guideline
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:

Test material

Constituent 1
Reference substance name:
Reaction mass of Amines, coco alkyl and ß-Alanine, N-(2-carboxyethyl)-, N-coco alkyl derivs. and ß-Alanine, N-coco alkyl derivs.
EC Number:
Molecular formula:
Reaction mass of Amines, coco alkyl and ß-Alanine, N-(2-carboxyethyl)-, N-coco alkyl derivs. and ß-Alanine, N-coco alkyl derivs.
Test material form:
other: paste
Details on test material:
- Lot/batch No.: EL 0085
- Name of test material: Reaction mass of Amines, coco alkyl and ß-Alanine, N-(2-carboxyethyl)-, N coco alkyl derives. and ß-Alanine, N coco alkyl derivs.
- Physical state: solid paste
- Expiry date: 15 May 2015
- Storage condition: in a cool place.

Test animals

Details on test animals or test system and environmental conditions:
- Source: breeder: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: approximately 8 weeks old on the day of treatment
- Mean body weight at study initiation: the males had a mean body weight of 358 g (range: 350 g to 368 g) and the females had a mean body weight of 241 g (range: 234 g to 249 g)
- Fasting period before study: yes, during the night before treatment
- Housing: the animals were housed by five from the same sex and group in polycarbonate cages with stainless steel lids
- Diet: SSNIFF R/M-H pelleted diet (free access)
- Water: tap water filtered with a 0.22 µm filter (free access)
- Acclimation period: at least 5 or 8 days before the beginning of the study.

- Temperature (°C): 22 ± 2°C
- Humidity (%): 50 ± 20%
- Air changes (per hr): approximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12 h/12 h.

IN-LIFE DATES: 19 June 2012 to 06 July 2012.

Administration / exposure

Type of coverage:
unchanged (no vehicle)
Details on dermal exposure:
- Area of exposure: 10% of body surface, dorsal site
- Type of wrap if used: hydrophilic gauze pad + adhesive hypoallergenic aerated semi-occlusive dressing + restraining bandage

- Removal of dressing: 24h post-exposure
- Washing: at 24h post-exposure, with a moistened cotton pad

- Amount(s) applied (volume or weight with unit): 2000 mg/kg
- Constant volume: no
- For solids, paste formed: yes
Duration of exposure:
24 hours
2000 mg/kg.
No. of animals per sex per dose:
5 animals per sex.
Control animals:
Details on study design:
- Duration of observation period following administration: 14 days
- Clinical observations: frequently during the hours following treatment; then, at least once a day.
- Body weight: just before treatment on day 1; then on days 8 and 15.
- Necropsy of survivors performed: yes (macroscopic).

Results and discussion

Effect levels
Dose descriptor:
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
No unscheduled deaths occurred during the study.
Clinical signs:
other: No clinical signs indicative of systemic toxicity were observed in any animals. Erythema (very slight to severe) and edema (very slight to moderate), followed by slight dryness of the application site, were observed in all females after application. Very
Gross pathology:
Scabs were seen on the skin of 1/5 females (No. Y23901). This observation which correlated with changes seen clinically during the course of the study was considered to be test item-related. Other changes (red discoloration of thymus and lungs and enlarged spleen) were considered to be part of the normal background of changes commonly seen in rats of this strain.

Any other information on results incl. tables

see Executive summary

Applicant's summary and conclusion

Interpretation of results:
not classified
Migrated information Criteria used for interpretation of results: EU
The dermal LD50 of the substance is >2000 mg/kg in rats.

Executive summary:

The objective of this study was to evaluate the potential toxicity of the test item following a single dermal application to rats.

This study was conducted in compliance with the principles of Good Laboratory Practices.



The test item was applied in its original form to the skin of five female then five male Sprague-Dawley rats at the dose-level of 2000 mg/kg. The application site was covered by a semi-occlusive dressing for 24 hours.

Each animal was observed at least once a day for mortality and clinical signs for 15 days. From day 2, any local reactions at the treatment site were also noted. Body weight was recorded on day 1 and then on days 8 and 15.

On completion of the observation period, the animals were sacrificed and then submitted for a macroscopic post-mortem examination.Macroscopic lesions were preservedin buffered formalin then destroyed at the finalization of the study reportas no microscopic examination was performed.



No unscheduled deaths and no clinical signs indicative of systemic toxicity were observed in any animals.

Scabs, slight or moderate thickening, very slight to severe erythema, very slight to moderate edema and/or very slight to moderate dryness were observed at application sites of all males and all females between days 2 andaddition, brownish discoloration was noted at application sites of 4/5 females on days 3 and 4.

Body weight of animals was considered to be unaffected by the test item treatment.

At necropsy, scabs were seen on the skin of one female.



The dermal LD50of the test item was higher than 2000 mg/kg in rats.

Therefore, the test item is not classified for acute toxicity by dermal route according to the criteria of CLP Regulation.