Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study - original study report available

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Colourless clear liquid with density 0.9347.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Iffa Credo (France)
- Age at study initiation: 6-8 weeks
- Weight at study initiation: 209-267g
- Fasting period before study:
- Housing: Individually in polycarbonate cages, bedding changed weekly.
- Diet (ad libitum): complete pelleted rat mouse maintenance diet (UAR formula A.04Cr, ex UAR Villemoisson, France)
- Water (ad libitum): softened and filtered mains tap water, bacterially and chemically checked twice annually.
- Acclimation period: 8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.5-24
- Humidity (%): 42-78
- Air changes (per hr): >10
- 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: Back and flanks, clipped
- % coverage: 10
- Type of wrap if used: semi-occlusive dressing composed of a perforated bandage (Creplux, Molinier) covering entire shaved area and trunk of the animal.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- details: washing at 24 hours using lukewarm water to remove any residual substance from skin.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2009mg/kg
Duration of exposure:
24 hours
Doses:
2009mg/kg (2.16ml/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 observations: clinical signs: 1, 2, 4 hours then daily. Cutaneous lesions evaluated daily from day 2. Weighing: days 1, 8, 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology (liver, heart, kidneys, lungs, skin)
Statistics:
No statistical evaluation of the results was required.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 2 009 mg/kg bw
Mortality:
None
Clinical signs:
None. No cutaneous lesions.
Body weight:
Three animals showed either no weight gain or weight loss over the study
Gross pathology:
No significant findings. An absence of faeces was seen in the same 3 animals that showed no weight gain/weight loss

Any other information on results incl. tables

The results on the three animals that showed weight loss and an absence of faeces are likely to be due to the animals not feeding. It is not possible to clearly attribute this to a treatment related response in the absence of any other clinical or pathology findings.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Executive summary:

In a guideline and GLP acute dermal toxicity limit study, the substance ethoxypropoxy propanol did not cause any mortality at a dose of 2009 mg/kg bw. No adverse clinical or pathological observations seen. There was evidence that 3 of the 10 animals stopped eating but this effect could not be attributed to treatment in the absence of any adverse clinical or pathological observations.