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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant, guideline study, available as unpublished report. No restrictions, fully adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OTS 798.1100 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
occlusive dressing used
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): E000044146
- Colourless liquid; disagreeable odour
- Specific gravity: AP = 0.98 (H2O = 1 at 39.2°F)
- Flash point: AP = 75°F
- Density: 0.9723 g/ml (as determined by UBTL)
- Analytical purity: no data
- Test material data on file with the study sponsor

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Camm Research, Wayne, New Jersey, USA
- Sex: 5 males and 5 females
- Age at study initiation: young adult
- Weight at study initiation: Approximately 2.0 - 3.0 kg
- Housing: Individually, in stainless steel, wire mesh bottom cages
- Diet: Agway rabbit feed ad libitum
- Water: ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature: 61 - 70°F
- Humidity: 40 - 60%
- Air changes: At least 10/h
- Photoperiod: 12 hrs dark/12 hrs light

IN-LIFE DATES: From: 6 March 1990 To: 20 March 1990

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal surface
- Type of wrap if used: occlusive (no further details reported)
- Hair clipped approximately 24 hours before dose application

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000mg/kg
- Individual volume adjusted based on density of test material and animal's bodyweight
Duration of exposure:
24 h
Doses:
2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of weighing: On arrival, the day of dosing, week 1 and at termination
- Clinical observations made hourly for the first 4 hours after dosing, and twice (a.m and p.m.) for the following 13 days
- Necropsy of survivors performed: yes
Statistics:
Not required

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: no mortality and no significant signs of toxicity at only dose tested
Mortality:
None
Clinical signs:
All animals showed one or more of the following observations: oedema, erythema, eschar, dried skin at the test site, abnormal faeces.
Body weight:
All animals gained weight during the study.
Gross pathology:
Eight of the ten animals showed one or more of the following observations: oedema, erythema, eschar, dried skin at the test site. The remaining two animals had no gross abnormalities.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The dermal LD50 of E000044146 is greater than 2000 mg/Kg.
Executive summary:

The acute dermal toxicity of E000044146 (CAS 68487-10-4) was investigated in groups of 5 male and 5 female rats. A single 24 hour application of 2000 mg/Kg in maize oil (20% w/v at 10 mL/Kg) was applied under an occlusive dressing.

There were no mortalities or significant signs of systemic toxicity and it can be concluded that the LD50 of E000044146 (CAS 68487-10-4) is > 2000 mg/Kg and no classification is warranted under GHS/CLP.