Registration Dossier

Administrative data

acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Apparently well conducted study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
according to guideline
OECD Guideline 402 (Acute Dermal Toxicity)
Principles of method if other than guideline:
Not applicable
GLP compliance:
Test type:
standard acute method
Limit test:

Test material

Constituent 1
Chemical structure
Reference substance name:
Dilauroyl peroxide
EC Number:
EC Name:
Dilauroyl peroxide
Cas Number:
Molecular formula:
dodecanoyl dodecaneperoxoate
Details on test material:
- labeling: LUPEROX LP
batch number: 9732 110402-010
Sponsor's filing number: GRL 0028/04
• description: white powder
• container: one plastic flask
• date of receipt: 13 May 2004
• storage conditions: at room temperature and protected from light
• purity: 99.1%
• expiry date: April 2005.

Test animals

Details on test animals or test system and environmental conditions:
Species, strain: rat, Sprague-Dawley Rj: SD (IOPS Han).
Reason for this choice: rodent species generally accepted by regulatory authorities for this type
of study.
Breeder: Janvier, Le Genest-Saint-Isle, France.
Age/weight: on the day of treatment, the animals were approximately 8 weeks old and had a
mean body weight ± standard deviation of 336 ± 21 g for the males and 220 ± 4 g for the females.
Acclimation: at least 5 days before the beginning of the study.
Identification: individually by earnotches.

The conditions in the animal room were set as follows:
• temperature: 22 ± 2°C
• relative humidity: 30 to 70%
• light/dark cycle: 12 h/12 h
• ventilation: approximately 12 cycles/hour of filtered, non-recycled air.
The temperature and relative humidity were under continuous control and recording. The records were checked daily and filed. In addition to these
daily checks, the housing conditions and corresponding instrumentation and equipment are verified and calibrated at regular intervals.
During the acclimation period, one to seven animals of the same sex were housed in polycarbonate cages with stainless steel lid (48 cm x 27 cm x 20 cm). During the treatment period, the animals were housed individually in polycarbonate cages with stainless steel lid (35.5 cm x 23.5 cm x 19.3 cm).
Each cage contained autoclaved sawdust (SICSA, Alfortville, France). Sawdust is analyzed by the supplier for composition and contaminant levels.

All the animals had free access to adapted pelleted diet (SSNIFF Spezialdiäten GmbH, Soest, Germany). Each batch of food is analyzed by the supplier
for composition and contaminant levels. The diet formula is presented in appendix 2. Drinking water filtered by a FG Millipore membrane (0.22
micron) was provided ad libitum. Bacteriological and chemical analyses of water are performed regularly by external laboratories. These analyses
include the detection of possible contaminants (pesticides, heavy metals and nitrosamines). No contaminants were known to have been present in the diet, drinking water or bedding material at levels which may be expected to have interfered with or prejudiced the outcome of the study.

Administration / exposure

Type of coverage:
unchanged (no vehicle)
Details on dermal exposure:
A limit test was performed by application of 2000 mg/kg of the test item to one group of ten animals (five males and five females).

On the day before treatment, the dorsal area of each animal was clipped (i.e. approximately 5 cm x 7 cm for males and 5 cm x 6 cm for females) using an electric clipper. Only animals with healthy intact skin were used for the study. A single dose of 2000 mg/kg of the test item in its original form was placed on a hydrophilic gauze pad (pre-moistened with 2 mL of purified water) and then applied to an area of the skin representing approximately 10% of the total body surface of the animals, calculated according to Meeh's formula (i.e. approximately 5 cm x 7 cm for the males and 5 cm x 6 cm
for the females). The test item and the gauze pad were held in contact with the skin for 24 hours by means of an
adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage. This dressing prevented ingestion of the test item by the
animal. On removal of the dressing, any residual test item was removed using a dry cotton pad. The dose applied to each animal was adjusted
according to the body weight determined on the day of treatment.
Duration of exposure:
24 hours
2000 mg/kg bodyweight
No. of animals per sex per dose:
Control animals:
Details on study design:
The animals were observed frequently during the hours following administration of the test item, for detection of possible treatment-related clinical
signs. Thereafter, observation of the animals was made at least once a day until day 15. Type, time of onset and duration of clinical signs were
recorded for each animal individually. From day 2, any local cutaneous reaction was recorded.

The animals were weighed individually just before administration of the test item on day 1 and then on days 8 and 15.

On day 15, all animals were killed by carbon dioxide asphyxiation. All study animals were subjected to a macroscopic examination as soon as
possible after death. After opening the thoracic and abdominal cavities, a macroscopic examination of the main organs (digestive tract, heart,
kidneys,liver, lungs, pancreas, spleen and any other organs with obvious abnormalities) was performed. No organ samples were taken.

Results and discussion

Preliminary study:
Not applicable
Effect levels
Dose descriptor:
Effect level:
> 2 000 mg/kg bw
Clinical signs:
Body weight:
A slightly reduced weight gain was obsrved in 2/5 females during the second week of the study.
Gross pathology:
No apparent abnormalities
Other findings:
No cutaneous reactions were observed

Any other information on results incl. tables


Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
The acute dermal LD50 of dilauroyl peroxide to rats was greater than 2000 mg/kg.
Executive summary:

The study was conducted to determine the acute dermal toxicity of dilauroyl peroxide to rats following the 24 hour application of 2000 mg/kg bodyweight. Test animals were observed for 14 days following application.

There were no mortalities or clinical signs of toxicity. There were no cutaneous reactions.