Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Test animals

Species:
rat
Strain:
other: RccHan:WIST (SPF)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratoies, The Netherlands
- Age at study initiation: 8 weeks (males) and 10 weeks (females)
- Weight at study initiation: 227.3-237.2g (males), 208.5-219.1g (females)
- Housing: In groups of five per sex in Makrolon type-4 cages during acclimatization. Individually in Makrolon type-3 cages during treatment and observation. Cages were equipped with wire mesh tops and standard softwood bedding.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: Five days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- 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: the back
- Type of wrap if used: The test item was applied evenly on the intact skin with a syringe and covered with a surgical gauze pad (ca. 5x5cm). The gauze pad was held in contact with skin by means of an adhesive hypoallergenic aerated semi-occlusive dressing and an elastic adhesive restrainer bandage wrapped around the abdomen.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with luke warm water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.2 ml/kg, calculated based on specific density of 0.9 g/mL


Duration of exposure:
24 hours
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 observations and weighing:The animals were examined daily during the acclimatization period and mortality, viability, clinical signs and local dermal signs were recorded. All animals were examined for clinical signs before treatment and approximately 0.5, 1, 2, 3 and 5 hours after treatment on test day 1 (with the clinical signs) and twice daily during test days 2-15. Body weights were recorded on test day 1 (prior to administration) and on test days 8 and 15. All animals were necropsied and macroscopically examined.
- Necropsy of survivors performed: yes/no
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:
Statistics:
No statistical analysis was performed.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No intercurrent deaths occurred during the course of the study.
Clinical signs:
No clinical signs were observed throughout the entire observation period. Slight erythema was observed in one of five males and in one of five females after test item application on test day 2. This sign of skin irritation was reversible in both animals. No local dermal signs were observed in any animal from test day 3 until the end of the observation period.
Body weight:
Two females slightly lost body weight after treatment, one of them in the first week after treatment , the second in both weeks after treatment. Otherwise the body wight of the animals was within the range commonly recorded for this strain and age.
Gross pathology:
No macroscopic findings were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 value of >2000 mg/kg bw is reported in a reliable study, conducted according to an appropriate OECD test guideline and in compliance with GLP.