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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1989-01-24 to 1989-04-17
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study is classified reliable without restriction because the study is well conducted, scientifically acceptable, well documented and appears to have followed OECD guideline 402 recommendations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
Individual data and necropsy data were not provided.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Oronite XS 1010
- Substance type: C10/C12 poly alpha olefin
- Physical state: Liquid
- Analytical purity: Not reported
- Composition of test material, percentage of components: Not reported, stated to be held by the sponsor
- Lot/batch No.: KWA 88-01217
- Stability under test conditions: Considered to be stable
- Storage condition of test material: ambient temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Bantin-Kingman, Inc., Fremont, California
- Age at study initiation: Male: 10 weeks old; Female: 11 weeks old
- Weight at study initiation: Male: 296 to 361 grams; Female: 212 to 240 grams
- Housing: Individually in stainless steel wire bottom cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 4 weeks


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 23°C
- Humidity (%): 30 to 50%
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours light


IN-LIFE DATES: From: 1989-01-24 To: 1989-02-07

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Trunks
- % coverage: Not reported
- Type of wrap if used: Plastic wrap then Peg wrap


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Wiped off with gauze pads moistened with mineral oil followed by dry gauze pads
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 milligram per kilogram body weight
- Constant volume: No



Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
Five animals per sex per dose
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Frequently on day of dosing, twice a day after except on weekends and holidays when it was once a day; weighting on days 1, 7, and 14
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs, body weight, pupil response (days 1, 7, and 14)
Statistics:
Body weight was analysed using a one-way analysis of variance.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
None
Clinical signs:
Skin irritation was noted in controls and treated animals, but the irritation was more severe and persistent in the treated animals with cracking and scarring occurring in the treated animals. Ocular discharge occurred in both the controls and treated animals.
Body weight:
There were no significant changes in body weight.
Gross pathology:
Necropsy at the end of the 14 day observation period revealed a dilated pelvis in the kidney of one male rat treated at 2000 mg/kg, but this was not considered to be a treatment-related.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information LD50 is greater than 2000 mg/kg bw Criteria used for interpretation of results: EU
Conclusions:
Oronite XS 101 at a dose of 2000 mg/kg causes increased skin irritation, but is not related to mortality or other clinical signs of toxicity. The dermal LD50 is greater than 2000 mg/kg.
Executive summary:

In an acute dermal toxicity study, five young adult Sprague-Dawley male and female rats were dermally exposed to undiluted Oronite XS 101 for 24 hours at a limit dose of 2000 mg/kg bw. Controls were sham treated. Animals then were observed for 14 days.

 

No mortality was observed. Mean body weight data indicates no significant difference between treated animals and their concurrent controls. Skin irritation was noted in controls and treated animals, but the irritation was more severe and persistent in the treated animals with cracking and scarring occurring in the treated animals. No other clinical signs of toxicity related to treatment were observed through the 14-day observation period. Necropsy at the end of the 14-day observation period revealed a dilated pelvis in the kidney of 1 male rat treated at 2000 mg/kg, but is not considered to be a treatment-related. The dermal LD50 was determined to be greater than 2000 mg/kg in male and female rats.

 

This study received a Klimisch score of 1 and is classified as reliable without restrictions because the study is well conducted, scientifically acceptable, well documented and appears to have followed OECD guideline 402 recommendations.