Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1997/10/17-1998/03/02
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 434 (Acute Dermal Toxicity - Fixed Dose Procedure)
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Development Detergent Alcohol 23731-52. Equivalent to Alcohols, C16-17, monobranched, type 2

- Physical state: Clear, colourless liquid.

- Analytical purity: Purity data are the responsibility of the sponsor.

- Storage condition of test material: Stored under nitrogen in the original container at room temperature.

Test animals

Species:
rat
Strain:
other: Crl:CD(SD)BR
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS

- Source: Charles River Laboratories, Inc., Portage, MI

- Age at study initiation: Young adult

- Weight at study initiation: 239-297 g

- Housing: Individual suspended mesh-bottom cages. The animals were maintained by the animal husbandry staff of WIL Research Laboratories Inc., in accordance with standard operating procedures.

- Diet: PMI Feeds Inc. Certified Rodent LabDiet 5002 (ad libitum)

- Water: reverse osmosis treated municipal water (ad libitum)



ENVIRONMENTAL CONDITIONS

- Temperature (°F): 71.6-72.1

- Humidity (%): 41.2-45.2

- Photoperiod (hrs dark / hrs light): 12/12


Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE

- Area of exposure: dorsal skin

- % coverage: 23% of total body surface

- Type of wrap if used: The test substance was held in contact with the skin under semi-occlusive dressing consisting of gauze bandaging that was secured with non-irritating tape.


REMOVAL OF TEST SUBSTANCE

- Washing (if done): The application sites were wiped with disposable paper towels moistenend with tepid tap water.

- Time after start of exposure: 24 hours


TEST MATERIAL

- Amount(s) applied (volume or weight with unit): 2.35 ml/kg

- Constant volume or concentration used: yes
Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
5F, 5M
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: The rats were observed at approximately 1,3 and 4 hours post dose on study day 0 and twice daily (morning and afternoon) thereafter for 14 days. Body weights were obtained and recorded on study days 0 (initiation), 7 and 14 (termination).

- Necropsy of survivors performed: yes

- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: The major organ systems of the cranial, thoracic and abdominal cavities were examined for all animals.
Statistics:
No statistical analysis was carried out.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
There were no deaths during the study.
Clinical signs:
Dried red and/or yellow material on the mouth, nose, eyes and/or urogenital area was observed on eight animals. These findings were considered unrelated to the test material as they are often noted for rats that have been bandaged/collared. There were no other clinical findings. With the exception of dried red material around the eyes noted for one rat on day 4, all animals appeared normal by day 2 or earlier and throughout the remainder of the observation period.
Body weight:
There were no remarkable changes or differences in body weights.
Gross pathology:
There were no gross necropsy findings for any examined tissues.
Other findings:
- Other observations: Four male rats had very slight erythema. Very slight oedema was noted on one rat. Desquamation was noted on nine animals. Four rats had focal eschar. A single male had exfoliation. Erythema and oedema completely subsided by day 7 and day 2, respectively. Focal eschar and desquamation persisted for one rat on day 14, while all dermal findings completely sibsided by day 14 or earlier for nine animals.

Any other information on results incl. tables

There were no deaths or test material-related clinical findings, remarkable body weight changes or necropsy findings. Very slight erythema and/or oedema was noted on four males. Additional dermal findings included desquamation for nine animals, focal eschar for four rats and exfoliation for one male. There were no other dermal findings. Based on the data obtained, the LD50 and the No-Observable-Effect Level (NOEL) for systemic toxicity of Development Detergent Alcohol 23721 -52 were found herein to be greater than 2000mg/kg when applied for 24 hours under semi-occlusion to the clipped, intact skin of male and female albino rats.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 value of above 2000mg/kg was determined in a reliable study conducted according to an appropriate test protocol, and in compliance with GLP.