Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
not reported
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guidelines and the study was conducted under GLP conditions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
- Physical state: liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: IFFA CREDO breeding centre (69210 Saint-Germain sur l'Arbresle)
- Age at study initiation: 6 - 7 weeks
- Weight at study initiation: 170 - 200 g (males); 140 - 180 g (females)
- Housing: individually in stainless steel cages
- Diet: UAR maintenance feed A04 ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 ºC
- Humidity (%): 30 - 70 %
- Air changes (per hr): 10 changes per hour

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
The animals were clipped one day before application of the test material on the lateral zone. On the day of application, the test material was spread over the entire dorsal zone, which was then covered by a gauze fastened by a tape of perforated adhesive plaster. After 24 hours of application, the dressing was removed, and the treated zone was rinsed with lukewarm water.
Duration of exposure:
24 hours
Doses:
1000 and 2000 mg/kg (preliminary study)
0 and 2000 mg/kg (definitive study)
No. of animals per sex per dose:
2 males and 2 females (preliminary study)
5 males and 5 females (definitive study)
Control animals:
other: yes, concurrent water
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: behaviour and mortality were observed immediately following test material application and again after 1, 2 and 4 hours. Daily observations continued thereafter for 14 days. Bodyweight was recorded on study days 1, 2, 8 and 15.
- Necropsy of survivors performed: yes. An autopsy was performed of all animals found dead or sacrificed at the end of the observation period. During autopsy, the abdominal and thoracic cavities were opened and an observation of the organs was carried out.
- Other examinations performed: condition of the skin was noted on study day 2 and each day thereafter.
Statistics:
Not reported.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No effects were noted at this treatment level.
Mortality:
None of the animals died during the study.
Clinical signs:
No behavioural anomaly was noted in the animals at the end of the treatment period or during the 14 day observation period that followed. Furthermore, there were no local effects recorded; no skin lesion (erythema or edema) was noted at the level of the site of application of the test material during the observation period.
Body weight:
The body weights of the treated animals were comparable to those of the controls.
Gross pathology:
No microscopic anomalies were detected at necropsy.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the study the acute dermal LD50 of the test material was determined to be in excess of 2000 mg/kg bw.
Executive summary:

The acute dermal toxicity of the test material was determined in accordance with standardised guidelines OECD 402 and EU Method B.3. In a preliminary study, groups of two male and two female rats were subject to a semi occlusive dermal application of 1000 or 2000 mg/kg test material. Animals were observed for a period of 14 days following treatment. Since none of the animals died, the definitive study was conducted with a single group of 5 males and 5 females treated with 2000 mg/kg test material and a further group of 5 males and 5 females treated with water alone. During the definitive study none of the animals died, no clinical signs were reported and the bodyweights of the treated animals were comparable to those of the controls. No detectable microscopic anomaly was detected in any of the animals at necropsy. Furthermore, no local effects were recorded with no skin lesion (erythema or edema) noted at the level of the site of application of the test material during the observation period. Therefore, under the conditions of the study, the acute dermal LD50 of the test material was determined to be in excess of 2000 mg/kg bw.