2,2-dimethyl-3-phenylpropanol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1981-11-09 to 1981-11-30

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable and well documented publication, probably technical pure quality was tested

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,2-dimethyl-3-phenylpropanol

EC Number:

236-400-9

EC Name:

2,2-dimethyl-3-phenylpropanol

Cas Number:

13351-61-6

Molecular formula:

C11H16O

IUPAC Name:

2,2-dimethyl-3-phenylpropan-1-ol

Test animals

Species:

rat

Strain:

other: BOR: WISW

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Firma Winkelmann, Versuchstierzucht, 4791 Borchen 1, Gartenstraße 300
- Weight at study initiation: Males: 162-190 g, females: 155-170 g
- Housing: Macrolon cages Typ III with maximal 5 rats
- Diet: Ssniff, Versuchtstierdiäten GmbH 4770 Soest/Westfalen
- Water: ad libitum, in Macrolon drinkbottles, 300 mL, Firma Becker & Co., 4620 Castrop Rauxel, tap water
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2 °C
- Humidity (%): 45-55 %
- Photoperiod: Room was artificially lit from 7 am to 7 pm

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 8 x 5 cm
- Type of wrap if used: gauze pads and several wrappings of plastic material

REMOVAL OF TEST SUBSTANCE
- Washing: After treatment the backs of all animals were secured with gauze pads and several wrappings of plastic material for 24 hours. Thereafter the patches were removed with wet disposable gauze
- Time after start of exposure: after 24 hours

TEST MATERIAL
- Amount(s) applied: 15 mL/kg
- Constant volume or concentration used: yes

Duration of exposure:

24 h

Doses:

15000 mg/kg bw (Value based on calculation with density (appx. 1 g/cm^3))

No. of animals per sex per dose:

5 males and 5 females
Two groups: The animals back of group I was abraded with a clean clipper blade so as to penetrate the horny layer of the epidermis, but without causing bleeding. The animals back of group II was left intact.

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: 2h, 4h, 24 h, 48 h, 72 h, 7 days, 14 days (clinical toxicological signs), 24 h, 3,7 and 14 days (skin alterations)
- Frequency of weighing: On day 0 and on day 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology

Statistics:

According to Draize et al.

Results and discussion

Preliminary study:

To determine the toxicity of the test item the following doses were tested in 2 rats per dose: 15, 10, 5, 2.5 and 1 mL/kg

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 15 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Value based on calculation with density (appx. 1 g/cm^3)

Mortality:

No mortality occured

Clinical signs:

other: No abnormalities observed

Gross pathology:

No abnormalities observed

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The study was carried out to determine the acute dermal toxicity potential of the test item. No mortality occured. The LD50 was determined to be >15000 mg/kg bw.

Executive summary:

The study was carried out on male and female rats to determine the acute dermal toxicity and the skin irritation potential of the test item.The study was conducted with albino Wistar animals that were collectively housed up to a maximum of 5 animals per cage (Macrolon type III). The room was artificially lit from 7 AM to 7 PM. The temperature was 21 ° C and relative humidity was 45-55%. Animals weighed 162-190 g (males) and 155-170 g (females) at the initiation of the study. After an acclimatization time of 7 days the test was initiated. Evaluation of clinical-toxicological signs was done individually at 2, 4, 24, 48, 72 h and 7 and 14 days postadministration of test compound. Any skin alterations were recorded at 24 h, 3, 7 and 14 days after application of test compound per Draize. Body weights were recorded on Day 0 and on Day 14. Immediately after death, a complete necropsy was performed on all acute- and late mortalities as well as on animals surviving the 14-day observation period. Prior to treatment the back of each animal was clipped (8 x 5 cm) with a small animal clipper. The animals back of group I was abraded with a clean clipper blade so as to penetrate the horny layer of the epidermis, but without causing bleeding. The animals back of group II was left intact. After treatment the backs of all animals were secured with gauze pads and several wrappings of plastic material for 24 hours. Thereafter the patches were taken off and the substance was removed with wet disposable gauze. Test compound was applied as supplied. The sample of test compound was weighed per animal and then dosed once dermal onto the scarified and intact skin, respectively, and thereafter secured as described above. No mortality occurred. The LD50 was determined to be >15000 mg/kg bw. Also no skin irritating potential was determined. An erythema score of 0 was determined. Also the edema score was 0.