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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 from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1989-01-24 to 1989-02-07
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: According to or similar to guideline study OECD 402 or Directive 92/69/EEC Method B3: GLP

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Oronite XS 101 (KWA 88-01217)
- Physical state: colorless liquid
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Bantin Kingman inc.
- Age at study initiation: 10 weeks (males); 11 weeks (females)
- Weight at study initiation: 296-361 g (males); 212-240 g (females)
- Fasting period before study: None
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 4 weeks


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23
- Humidity (%): 30-50
- Photoperiod (hrs dark / hrs light): 12/12


Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: trunk
- Type of wrap if used: Test material was held in contact with the animals skin by plastic film wrapped around the trunk, and Peg Wrap was placed over the plastic to prevent tearing.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): after exposure period, excess was wiped off with gauze
- Time after start of exposure: 24h


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.650g (+/- 0.047) for males; 0.445 (+/- 0.021) for females
- Constant volume or concentration used: yes



Duration of exposure:
24-hour exposure period
Doses:
2.0g/kg
No. of animals per sex per dose:
Five untreated animals of each sex; five treated (2.0g/kg) animals of each sex
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observed frequently on day of dosing and twice daily thereafter except weekends and holidays when animals were observed once a day. Animals were weighed immediately before dosing and on Days 2, 7, and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: pupil response was examined before dosing and on Days 1, 7, and 14.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality was observed.
Clinical signs:
No signs of toxicity were seen. Skin irritation was observed in both control and treated animals; however irritation was more severe and persistent in treated animals with cracking and scarring also being observed.
Body weight:
No significant differences in mean body weights between control and treated animals
Gross pathology:
A dilated pelvis was observed at necropsy in the kidney of one male from the 2.0g/kg dose group. It has been determined from previous studies that this is a common finding in Sprague-Dawley Rats and not treatment-related.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The dermal LD50 for Oronite XS 101 is greater than 2000 mg/kg. This finding does not warrant classification of Oronite XS 101 as an acute dermal toxicant under EU GHS guidelines and does not warrant classification under EU requirements for dangerous substances and preparations.
Executive summary:

Oronite XS 101 was applied to the clipped backs of ten Sprague-Dawley rats for 24 hours at a dose of 2000mg/kg under occlusive binding to assess the acute dermal toxicity.  Five clipped, untreated animals of each sex were similarly wrapped and served as sham controls. The animals were observed frequently on the day of dosing for any physiological or behavioral abnormalities and daily thereafter.  No deaths or signs of systemic toxicity were observed.  Skin irritation including erythema, cracking and scarring was seen in both control and treated animals; however, irritation was more severe and persistent in treated animals than in controls.  The dermal LD50 for Oronite XS 101 is greater than 2000 mg/kg.  This finding does not warrant the classification of  Oronite XS 101 as an acute dermal toxicant under EU GHS guidelines and does not warrant classification under EU requirements for dangerous substances and preparations.