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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
From July 18, 2008 to August 20, 2008
1 (reliable without restriction)

Data source

Reference Type:
study report

Materials and methods

Test guideline
according to guideline
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
Limit test:

Test material

Constituent 1
Chemical structure
Reference substance name:
Cas Number:
Molecular formula:
Specific details on test material used for the study:
Test material name in the study: PF-03394197-11
Lot Number: PF-01/115802/138A

Test animals

Crj: CD(SD)
Details on test animals or test system and environmental conditions:
- Rationale for alternative/additional species to rat (if applicable)
- Source: Charles River, Portage, Michigan
- Females (if applicable) nulliparous and non-pregnant: [yes/no]
- Rationale for use of males (if applicable)
- Age at study initiation: Approximately 7 weeks
- Weight at study initiation: Male: 220 to 225 g Female: 167 to 176 g
- Fasting period before study:
- Housing: Individual, stainless steel suspended wire mesh-type cages
- Historical data:
- Diet (e.g. ad libitum): Block Lab Diet® Certified Rodent Diet #5002, PMI Nutrition International, Inc. Ad libitum.
- Water (e.g. ad libitum): Automatic watering system, Ad libitum.
- Acclimation period: 7 days
- Microbiological status when known
- Method of randomisation in assigning animals to test and control groups

- Temperature (°C): 22 (±3) °C
- Humidity (%): 30 to 70%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): Fluorescent lighting was provided for approximately 12 hours per day. The dark cycle was interrupted intermittently due to study-related activities.

Administration / exposure

Type of coverage:
other: Mineral oil
Details on dermal exposure:
- Area of exposure: back of each animal
- % coverage: no less than 10% of the body surface area
- Type of wrap if used: the area was wrapped with gauze and secured with a non-irritating tape.

- Washing (if done): the wrappings were removed and the residual test article was removed using tepid tap water.
- Time after start of exposure: 24 hours
Duration of exposure:
24 hours
2000 mg/kg
No. of animals per sex per dose:
5 males and 5 females
Control animals:
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The test animals were observed for clinical signs approximately 0.5, 2, and 4 hours after dosing on Day 1. Thereafter, the animals were observed for clinical signs once daily for 14 days. Observations included, but were not limited to, evaluation of the skin, fur, eyes, ears, nose, oral cavity, thorax, abdomen, external genitalia, limbs and feet, respiratory and circulatory effects, autonomic effects such as salivation, nervous system effects including tremors, convulsions, reactivity to handling, and bizarre behavior. Individual body weights were obtained on the day of arrival, just prior to test article administration (Day 1) and
weekly thereafter.
- Necropsy of survivors performed: Complete necropsy examinations were performed under procedures approved by a veterinary pathologist on all animals euthanized at scheduled necropsies. Euthanasia was by carbon dioxide inhalation followed by exsanguination from the abdominal vena cava. The animals were examined carefully for external abnormalities including palpable masses. The skin was reflected from a ventral midline incision, and any subcutaneous masses were identified and correlated with antemortem findings. The abdominal, thoracic, and cranial cavities were examined for abnormalities, and the organs were removed, examined, and the tissues and carcasses were discarded.

Results and discussion

Effect levels
Key result
Dose descriptor:
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
All animals survived to the scheduled necropsy on Day 15.
Clinical signs:
There were no treatment-related clinical findings. There were clinical findings that may have
been due to the wrapping and the use of Elizabethan collars that included red or brown
material around the eyes and nose and brown skin discoloration of the thoracic region and
sparseness of hair in the abdominal region which were observed very occasionally.
Body weight:
There were no treatment-related changes in body weight gains. The body weight gain of one
female animal (number 3006) was slightly lower than expected; however the body weight
gains of the remaining animals over the two week study period were considered normal.
Gross pathology:
No test article-related macroscopic observations were made in male or female rats.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
The dermal LD50 of the test item was greater than 2000 mg/kg in male and female rats.
Executive summary:

The acute dermal study is performed according to OECD Guideline 402 under GLP. The dermal LD50 of the test item was greater than 2000 mg/kg in male and female rats.