4-Penten-2-ol, 3,3-dimethyl-5-(2,2,3-trimethyl-3-cyclopenten-1-yl)-, (4E)-

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 08 April to 06 May 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Study performed according to EU Method B.3 and in compliance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Principles of method if other than guideline:

not applicable

GLP compliance:

yes (incl. QA statement)

Remarks:

UK GLP Compliance Programme (inspected on 1990-06-19/signed on 1990-10-05

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(-)-(2S,4E)-3,3-Dimethyl-5-[(1R)-2,2,3-trimethyl-3-cyclopenten-1-yl]-4-penten-2-ol

Cas Number:

163579-54-2

Molecular formula:

C15H26O

IUPAC Name:

(-)-(2S,4E)-3,3-Dimethyl-5-[(1R)-2,2,3-trimethyl-3-cyclopenten-1-yl]-4-penten-2-ol

Constituent 2

Reference substance name:

(-)-(2R,4E)-3,3-Dimethyl-5-[(1R)-2,2,3-trimethyl-3-cyclopenten-1-yl]-4-penten-2-ol

Cas Number:

163579-53-1

Molecular formula:

C15H26O

IUPAC Name:

(-)-(2R,4E)-3,3-Dimethyl-5-[(1R)-2,2,3-trimethyl-3-cyclopenten-1-yl]-4-penten-2-ol

Test material form:

liquid

Details on test material:

- Name of test material (as cited in study report): ST 02 C 88
- Substance type: pure active substance
- Physical state: colourless liquid
- Lot/batch No.: A/D/33906 (Toxicol reference N°)
- Storage condition of test material: ca. 4°C under nitrogen in the dark

Test animals

Species:

rat

Strain:

other: Crl:CD(SD)BR (VAF plus)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Limited, Margate, Kent, England
- Age at study initiation: healthy young animals
- Weight at study initiation: 231-248g (males) 216-225g (females)
- Fasting period before study: no
- Housing: Animals were individually housed in grid bottomed cages suspended over cardboard lined excreta trays. Cardboard tray liners were changed as often as necessary to maintain hygiene.
- Diet (e.g. ad libitum): ad libitum, quality certified
- Water (e.g. ad libitum):ad libitum, quality certified
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22 °C
- Humidity (%): 37-51%
- Air changes (per hr): no data, air conditionned
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: back
- % coverage: no data
- Type of wrap if used: The treated site was covered with a pad of surgical gauze 4 plies thick. This was secured in position by a length of 5.0cm wide 'Elastoplast' elastic adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle swabbing with cotton wool soaked in warm water.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.2 mL/kg bw
- Constant volume or concentration used: yes

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

Preliminary range finding study: 1 male + 1 female
Limit test: 5 males + 5 females

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: shortly after dosing, after 30 min, after 1, 2 and 4 hours, daily thereafter for 14 consecutive days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, signs of toxicity, body weight,organ weights, histopathology.

Statistics:

None (limit test at one dose level of at least 2000 mg/kg)

Results and discussion

Preliminary study:

A preliminary range finding study was conducted at a dose level of 2000mg/kg bodyweight using one male rat and one female rat.
Following dosing, animals were examined at frequent intervals on the day of dosing and daily thereafter for 7 days. At the end of this period they
were killed and discarded without necropsy. No deaths occurred and both animals appeared throughout the observation period, therefore the main study consisted of a limit test conducted at a dose level of 2000mg/kg bodyweight, using one group of 5 male and 5 female rats.

Effect levels

Effect levels 1

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

Effect levels 2

Sex:

male/female

Dose descriptor:

LD0

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths

Clinical signs:

There were no signs of systemic toxicity

Body weight:

All animals showed expected gains in bodyweight over the study period

Gross pathology:

The necropsy findings were of low incidence and were considered not to be treatment related.

Other findings:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Dermal LD50Combined > 2000 mg/kg bw. Under the test conditions, the test material is not classified according to the annex VI of the Regulation EC No. 1272/2008 (CLP).

Executive summary:

In a limit acute dermal toxicity study performed according to the EU B.3 test method and in compliance with GLP, young adult Crl:CD(SD)BR (VAF plus) rats were occlusively exposed to undiluted test material for 24 hours at dose of 2000 mg/kg bw. In a preliminary range-finding study, the test material was administered to one male and one female rat. Both of these animals appeared outwardly healthy throughout the 7 day observation period. In the main study, the test material was administered to 5 males and 5 females. After 24 hours, the dressings were removed and the treated sites were washed with warm water. The animals were observed for 14 days and at the end of this period they were killed and necropsied.

No deaths occurred and all animals remained outwardly healthy throughout the study. There was no adverse effect on bodyweight gain in animals of either sex. Necropsy findings were of low incidence and are considered not to be treatment related.

 

Dermal LD₅₀Combined > 2000 mg/kg bw

 

Under the test conditions, the test material is not classified according to the annex VI of the Regulation EC No. 1272/2008 (CLP).

This study is considered as acceptable and satisfies the requirement for acute dermal toxicity endpoint.