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Diss Factsheets

Administrative data

acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
February 06 1991 to February 21 1991
1 (reliable without restriction)

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
according to guideline
other: 84/449/EWG, B.3
GLP compliance:
Test type:
standard acute method
Limit test:

Test material

Constituent 1
Test material form:
Specific details on test material used for the study:
Not specified

Test animals

Details on test animals or test system and environmental conditions:
Body weight (on receipt): Males: 225-250 g
Females: 200-225 g
Age (on receipt): About 7-9 weeks
Supplier: Charles River Italia S.p.A. Via Indipendenza, 11, 22050 - CALCO (Como),
Shipping slip number: 00621 dated Jan. 21, 1991
Acclimation: at least 5 days before the start of the test. Animals were observed daily to ascertain their fitness for the study.
Housing: 1 animals/cage in air-conditioned rooms.
- Temperature: 22 ° C ± 2
- Relative humidity: 55% ± 10
- Air changes: about 20/hour filtered on HEPA 99.97%.
- HEPA 99.97%
- Light: 12 hour cycle (7 a.m. - 7 p.m.)
- Cage size: grill cages cm 40.5x38.5x18h with stainless steel feeder. The waste that
dropped through the grill bottom on removable paper was periodically disposed of.
Animal identification: By nicks or tipping's of the outer ear. Cage card gave experiment number, dosage group, sex and date of administration.
Diet: GLP 4RF21 pelleted diet produced by Charles River Italia' s feed licensee Yucedola
S.r.l., Settimo Yilanese. The declared contents, on the label, on dry matter basis (moisture 12%), were:
crude protein 13.50%
crude fat 3.00%
crude fiber 6.00%
ash 7.00%
The diet was supplemented by the Producer with vitamins and trace elements. The Producer supplies a certificate of anal:-sis for nutrients and contaminants, the levels of which are within the limits proposed by EPA-TSC-4 (44FR:4053-44093, July 26, 1979). RBM has the animal feed re-analyzed at Least twice a year for bacterial contamination. The diet was available "ad libitum" to the animals.
Water: from the municipal water main system. water is filtered and distributed "act· libitum" to the animals by an automatic valve system.
Periodically drinking water is analyzed for microbiologic count. heavy metals, other contaminants (e.g. solvents, pesticides) and other chemical and physical characteristics. The acceptable limits of quality of the drinking water were those defined in EEC Directive 80/778.

Contaminants that might interfere with the objectives of the study were not expected to be present in diet or drinking water.

Administration / exposure

Type of coverage:
unchanged (no vehicle)
Details on dermal exposure:
Dermal exposure:
Preparation of animals skin: Approximately 24 hours before the test, fur was clipped from the dorsal and ventral area of the trunk of the test animals. Care was taken to avoid abrading the skin which could alter its permeability.
An area of about 6x5 cm of the body dorsal surface was cleared for the application of the test article. This area corresponding to about 10% of the total body surface.

Administration of the test article:
By uniform application onto the cleared area. The treated area was covered with a porous gauze dressing fixed to the skin with hypoallergenic non-irritating tape (Micropore, 3M Italia, Milano).
The test side was further covered in a suitable manner in order to ensure that the animals could not ingest the test substance. At the end of the exposure period the residual substance was wiped off.
Duration of exposure:
24 hours exposure
single does of 2000 mg/Kg body weight
No. of animals per sex per dose:
5 males + 5 females/group
Control animals:
not specified
Details on study design:
Study design
Administration route: epidermal
Reason for selection of administration route : Possible accidental exposure for humans.
Administration frequency: Single.
Exposure period: About 24 hours.

Experimental design: One group of 5 rats/sex was administered a single dose of 2000 mg/Kg of the test article.
Individual dosages were based on body weight taken just before treatment.

Observation period: 14 days after the administration.
Observation of clinical signs: On exposure day at 30 minutes, 2, 4 and 6 hours on the following 14 days the animals were observed twice a day for behavioral and clinical changes.

Observation of mortality: Twice a day, early in the morning and late in the afternoon.

Body weight: Once pre-trial, on the administration day (day 1 to calculate the administration volumes) and on days 8 and 15.

Gross pathology: On all the animals (fasted overnight) at the termination of the 14 days post exposure observation period.
Animals were killed by excision of the femoral arteries, after i.p. anesthesia with 5% sodium pentobarbital.

Histology: Since no changes were found at necropsy, histological examination was not performed.
Since no mortality occurred at the limit dose of 2000 mg/Kg, the LD50 was not calculated.

Results and discussion

Effect levels
Key result
Dose descriptor:
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
No mortality was observed in animals treated at 2000 mg/Kg (limit dose) during the post-treatment observation period.
Clinical signs:
other: The rats did not show any clinical sign or change in behavior and no reaction was observed at the application site.
Gross pathology:
No changes were observed in the animals killed at the end of the study.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
The test article ANOX - BF, when administered by dermal route to rat, under the conditions adopted in this experiment, did not cause mortality nor toxic effects at the limit dose of 2000 mg/Kg.
The LD50 by dermal route is higher than 2000 mg/Kg
Executive summary:

A acute dermal toxicity study was carried out in rats treated with test article ANOX – BF,  according to test guideline 84/449/EWG, B.3, in compliance with GLP.

Experimental data obtained from a toxicity study in which Sprague Dawley Crl:CD (SD) BR rats ( 5 males and 5 females/group) received a single dermal administration of the test article ANOX – BF at the dose of 2000 mg/Kg (24 hour exposure) are provided.

The animals were observed for 14 days after the patch removal.

No deaths occurred as a result of treatment.

No clinical signs or behavioural alterations were observed in any animal.

At the application site, no dermal reactions were detected.

No significant changes in the body weight gain were observed.

No changes were found at the gross pathology examination performed at the end of the observation period.

In conclusion, the test article ANOX - BF, when administered by dermal route to rat, under the conditions adopted in this experiment, did not cause mortality nor toxic effects at the limit dose of 2000 mg/Kg.

The LD50 by dermal route is higher than 2000 mg/Kg