Registration Dossier

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: Guide line study without deviations

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report Date:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: CD / Crl: CD(SD)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories
Research Models and Services,
Germany GmbH
Sandhofer Weg 7
97633 Sulzfeld
Germany
- Age at dosing: Males: approx. 8 weeks, females: approx. 9 weeks
- Weight at dosing: Males: 218 - 245 g, females: 204 - 222 g
- Fasting period before study: 16 hours before administration; only tap water was then available ad libitum.
- Housing: Granulated textured wood (Granulat A2, J. Brandenburg, 49424 Goldenstedt, Germany) was used as bedding material for the cages. The cages were changed and cleaned twice a week.
During the 14-day observation period the animals were kept singly in MAKROLON cages (type III plus) at a room temperature of 22°C ± 3°C (maximum range) and a relative humidity of 55% ± 15% (maximum range). Deviations from the maximum range caused for example during cleaning procedures are dealt with in SOPs.
- Diet: Commercial diet, ssniff® R/M-H V1534 (ssniff Spezialdiäten GmbH, 59494 Soest, Germany; see Appendix 1 'Composition of the Diet') served as food.
- Water: ad libitum
- Acclimation period: no information

ENVIRONMENTAL CONDITIONS
- Temperature: 22°C ± 3°C (maximum range)
- Humidity: 55% ± 15% (maximum range).
- Air changes (per hr): no information
- Photoperiod (hrs dark / hrs light): The rooms were lit (150 lux at approx. 1.50 m room height) and darkened for periods of 12 hours each.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: (5 cm x 6 cm, approx. 1/10 of body surface).
- Type of wrap if used: The test item was held in contact with the skin with 8
layers of gauze. The gauze was covered with a plastic sheet and secured with adhesive plaster strips4

REMOVAL OF TEST SUBSTANCE
- Washing: no
- Time after start of exposure: two weeks

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.04 mL/kg b.w.
Duration of exposure:
Two weeks
Doses:
2000 mg/kg b.w.
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: Following administration, observations were made and recorded systematically with individual records being maintained for each animal. Observations were performed before and immediately, 5, 15, 30 and 60 min, as well as 3, 6 and 24 hours after administration. All animals were observed for a period of 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality withion 14 days
Clinical signs:
None
Body weight:
Males: 231.2 g (start) - 344.4 g (after 14 days)
Females: 216 g (start) - 246.2 g (after 14 days)
No inhibition of body weight gain
Gross pathology:
No findings

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the present test conditions, a single dermal administration of 2000 mg test substance/kg b.w. did not reveal any signs of toxicity. No death was recorded within the test period (one dosing day and 14 days of recovery).
Executive summary:

The acute dermal toxicity of 1 -propanone, 2-hydroxy-2-methyl-, 1-(4-C10-13-alkylphenyl) derivs. was examined in a study after a single dermal application to rats according to OECD Guideline 402 (Acute dermal toxicity). One dose level of 2000 mg/kg b.w. was

employed (limit test) to male and female test animals.

Under the present test conditions, a single dermal administration of 2000 mg test substance/kg b.w. did not reveal any signs of toxicity. No death was recorded within the test period (one dosing day and 14 days of recovery).

All animals gained the expected weight throughout the whole study period.

No skin reactions were observed at the application site.

No signs of abnormalities were noted at necropsy.

The LD50 dermal in rats is greater than 2000 mg/kg.