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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
other information
Study period:
October 2013
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
according to guideline
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:

Test material

Constituent 1
Chemical structure
Reference substance name:
EC Number:
Cas Number:
Molecular formula:
Test material form:

Test animals

Details on test animals or test system and environmental conditions:
- Source: Harlan Laboratories S.r.l., S.Pietro al Natisone (UD), Zona Industriale Azzida, 5733040, Italy
- Age at study initiation: young adult rats
- Weight at study initiation: approx. 215 - 283 g
- Housing: Type II polypropylene/polycarbonate cages; individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 6 days

- Temperature (°C): 19.7 - 23.9
- Humidity (%): 35 - 58
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
unchanged (no vehicle)
Details on dermal exposure:
The backs of the animals were shorn (approximately 10% area of the total body surface) approximately 24 hours prior to the treatment. Only those animals without injury or irritation on the skin were used in the test.
On test day 0, the test item was applied at a single dose of 1000 or 2000 mg/kg bw, applied uniformly over the skin by use of a gauze pad (ca. 5 cm x 5 cm), and remained on the skin throughout a 24- hour exposure period (surviving animals). Sterile gauze pads were placed on the skin of rats at the site of application. These gauze pads were kept in contact with the skin by a patch with adhesive hypoallergenic plaster. The entire trunk of the animal was then
wrapped with semi occlusive plastic wrap for 24 hours (where applicable). At the end of the exposure period, residual test item was removed, using body temperature water.
Duration of exposure:
24 h
1000, 2000 mg/kg body weight
No. of animals per sex per dose:
5 males and 5 females /1000mg/kg bw
1 male and 1 female / 2000 mg/kg bw
Control animals:

Results and discussion

Effect levels
Dose descriptor:
Effect level:
>= 1 000 - <= 2 000 mg/kg bw
Based on:
test mat.
Mortality was observed (1/1 male and 1/1 female) on day 0 at the dose level of 2000 mg/kg bw.
No mortality was observed at the dose level of 1000 mg/kg bw.
Clinical signs:
other: There were no systemic clinical signs noted in any animals throughout the study.
Gross pathology:
Macroscopic Findings:
One male and one female dosed at 2000 mg/kg bw were found dead on Day 0. A specific cause of death was not determined for these animals.
Dark/red discoloration of the non-collapsed/collapsed lungs and red liquid material at the periorbital fur were regarded as agonal or post mortem in nature.
Terminal (Day 14):
Scars 2x2/3 cm in size at the application site were observed in 4/5 females at a dose level of 1000 mg/kg bw. No gross changes were seen in the males dosed at 1000 mg/kg bw. Therefore, in the absence of a control group or of further histopathology evaluation the definitive attribution of these local observations to the test item cannot be excluded or confirmed under the conditions of this study.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Executive summary:

After a single topical administration of the undiluted test material to rats, followed by a fourteen-day observation period, mortality was observed (1/1 male and 1/1 female) on day 0 at the dose level of 2000 mg/kg bw. No mortality (0/10) was observed at the dose level of 1000 mg/kg bw. No systemic clinical signs were observed after treatment. There were no treatment related effects on body weight or body weight gain. Thus the median lethal dose of the neat test material after a single dermal administration was found to be between 1000 and 2000 mg/kg bw in male and female rats.