3-(Hydroxymethyl)-1-pentene

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

July 25, 2006 - September 22, 2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

02-1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

12-1992

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-ethylbut-3-en-1-ol

EC Number:

610-949-8

Cas Number:

53045-70-8

Molecular formula:

C6H12O

IUPAC Name:

2-ethylbut-3-en-1-ol

Test material form:

liquid

Test animals

Species:

rat

Strain:

Wistar

Remarks:

HsdCpb:WU

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: F. Winkelmann, Borchen, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 7 - 11 weeks
- Weight at study initiation: 222 - 248 g
- Housing: separately in type III Makrolon cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 21
- Humidity (%): 51 - 68
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From days 1 to 15

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

The backs and abdomens of the rats were shaved with an electric hair clipper not later than one hour before treatment. The test material (2.37 mL/kg) was spread on the shaven skin in an area of 6*6 cm and covered with a gauze patch. This was kept in place by a self-adhesive fabric. The time of exposure was 24 hours. Then the gauze and adhesive fabric were removed and any remaining test material was wiped off carefully

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 m / 5 f

Control animals:

no

Details on study design:

Observation for clinical symptoms: On the day of treatment the general condition and motility of the rats were slightly affected by the tape. It was difficult to distinguish between slight clinical findings and reactions due to fixation by the tape. The behaviour and general condition of all rats were monitored for at least 6 hours after administration and then checked daily.
Bodyweight: All animals were weighed before treatment and on days 2, 4, 6, 8, 11, 13, and 15 of the experimental part.
Pathology: All rats were sacrificed at the end of the experimental part and subjected to a gross pathological investigation.

Statistics:

Standard statistical methods have been applied for data processing.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

no indication of skin irritation up to the relevant limit dose level

Mortality:

All rats survived the observation period.

Clinical signs:

other: No signs of toxicity were detected in any rat.

Gross pathology:

The gross pathological examination revealed no organ alterations.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In this GLP study performed according to OECD GL 402, the test item was tested for acute toxicity in rats after dermal administration of 2000 mg/kg. Based on the result of this study, the test item can be considered to have no acute toxic potential and to have a LD50 value higher than 2000 mg/kg.

Executive summary:

Study design

In this GLP study performed according to OECD GL 402, the test item was tested for acute toxicity in rats after dermal administration of 2000 mg/kg. The liquid test material was spread on the shaven skin in an area of 6*6 cm and covered with a gauze patch, which was kept in place by a self-adhesive fabric. The time of exposure was 24 hours, then the gauze and adhesive fabric were removed and any remaining test material was wiped off carefully.

 

Results

No signs of toxicity were detected and there were no deaths during the course of the study. The body weight development was inconspicuous and also the gross pathological examination revealed no organ alterations.

 

Conclusion

Based on the result of this study, the test item can be considered to have no acute toxic potential and to have a LD50 value higher than 2000 mg/kg after dermal application to rats.