1-Propanone, 2-hydroxy-2-methyl-, 1-(4-C10-13-alkylphenyl) derivs.

Acute Toxicity: dermal

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1-Propanone, 2-hydroxy-2-methyl-, 1-(4-C10-13-alkylphenyl) derivs.

Cas Number:

1001416-18-7

Molecular formula:

Not applicable - UVCB

IUPAC Name:

1-Propanone, 2-hydroxy-2-methyl-, 1-(4-C10-13-alkylphenyl) derivs.

Test animals

Species:

rat

Strain:

other: CD / Crl: CD(SD)

Sex:

male/female

Details on test animals or test system 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:

other: None

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.