2-hydroxypropyl [(1R,2S,5R)-2-isopropyl-5-methyl-cyclohexyl] carbonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1993-10-11 to 1993-10-15

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Deviations from the OECD 404 (2015): 4 animals were tested instead of 3. Systemic effects were not investigated. 5 test item concentrations were tested (undiluted, 1, 5, 10, and 25 %). 30 min. observation was conducted instead of a 1 h observation. In one animal the skin effects were not reversible by 72 h, but still the study was terminated.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1992-07-17

Deviations:

yes

Remarks:

4 animals were tested instead of 3. Toxic effects not investigated. 5 test item concentrations were tested. 30 min. observation was conducted instead of a 1 h observation. skin effects in 1 animal not reversible by 72 h, but the study was terminated.

GLP compliance:

yes (incl. QA statement)

Remarks:

signed 1993-09-23

Test material

Test material information

Constituent 1

Reference substance name:

1-[({[(1R,2S,5R)-5-methyl-2-(propan-2-yl)cyclohexyl]oxy}carbonyl)oxy]propan-2-ol

EC Number:

607-858-0

Cas Number:

260781-16-6

Molecular formula:

C14H26O4

IUPAC Name:

1-[({[(1R,2S,5R)-5-methyl-2-(propan-2-yl)cyclohexyl]oxy}carbonyl)oxy]propan-2-ol

Test animals

Species:

rabbit

Strain:

other: Mol:Russian

Details on test animals or test system and environmental conditions:

TEST ANIMALS - SPF albino rabbits
- Weight at study initiation: 2.3 - 2.9 kg
- Housing: kept in single PPL cages, 45 x 55 cm, with perforated floor
- Diet (ad libitum): feed pellets "Altromin 2123"
- Water (ad libitum): drinking water acidified with hydrochloric acid to pH 2.5
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature: 21 ± 3°C
- Relative humidity: 55 ± 15%
- Air changes: 10 times/hour
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent negative control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL of the undiluted test substance


NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 0.5 mL of diethyl phthalate

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

4 female rabbits

Details on study design:

TEST SITE
- Area of exposure: area of 10 x 10 cm on the back

- Type of wrap if used: to a patch (2.5 x 2.5 cm) the test substance or vehicle was applied and the patch were placed on the back. The gauze patch was secured with adhesive type and fixed with Scanpor tape loosely wound round the trunk.

REMOVAL OF TEST SUBSTANCE
- Washing: treated skin was cleaned with soap and lukewarm water
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
30 minutes as well as 24, 48, and 72 hours after application

SCORING SYSTEM: according to the Draize scale
- Method of calculation: scores for erythema and oedema formation for the last 3 readings of each rabbit (24, 48 and 72 hours) for each test concentration were obtained separately and divided by 3. The results are the mean scores for erythema and oedema formation of the individual rabbit.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: reading of 100% test concentration

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: reading of 100% test concentration

Results 3

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #2

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: reading of 100% test concentration

Results 4

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: reading of 100% test concentration

Results 5

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

other: not specified, if skin reaction was reversible, since the observation period lasted only 72 hours and was not extended unitl reversal occurred or 14 days had elapsed.

Remarks on result:

other: reading of 100% test concentration

Results 6

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: reading of 100% test concentration

Results 7

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #4

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

other: observation was only made at the 48 hour observation

Remarks on result:

other: reading of 100% test concentration

Results 8

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: reading of 100% test concentration

Irritant / corrosive response data:

At the one hour reading very slight erythema (grade 1) was observed in three rabbits. One of these rabbits still showed a very slight erythema (grade 1) at the 24 and 48 hour observations and another rabbit of these three rabbits showed the same reaction at the 24, 48, and 72 hours observations.
Lastly, one rabbit only showed very slight erythema (grade 1) at the 48 hour observation.
Apart from that no signs of skin reaction were recorded.

Any other information on results incl. tables

TEST CONCENTRATIONS:100%, 25 %, 10 %, 5 %, and 1 % (w/w) plus vehicle

No signs of skin irritation were recorded.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The substance is not irritating to the skin based on an in vivo study (OECD 404).
According to Regulation (EC) No 1272/2008 and subsequent adaptations, the substance does not require classification as skin irritant.

Executive summary:

The skin irritation potential of the substance was investigated according to the OECD guideline 404 (1992). A single dose of 0.5 mL of the undiluted substance was applied to the skin of four female Mol: Russian rabbits and covered semi-occlusive for an exposure period of 4 hours. The test sites were examined for skin reactions after test item treatment and scored according to the Draize scale after 30 minutes as well as 24, 48 and 72 hours after application.

The following results were recorded:

Animal #1

Erythema: 0

Oedema: 0

Animal #2

Erythema: 0.67

Oedema: 0

Animal #3

Erythema: 1

Oedema: 0

Animal #4

Erythema: 0.33

Oedema: 0

At the one hour reading very slight erythema (grade 1) was observed in three rabbits. One of these rabbits still showed a very slight erythema (grade 1) at the 24 and 48 hour observations and another rabbit of these three rabbits showed the same reaction at the 24, 48, and 72 hours observations. Lastly, one rabbit only showed very slight erythema (grade 1) at the 48 hour observation. Apart from that no signs of skin reaction were recorded.

According to Regulation (EC) No 1272/2008 and subsequent adaptations, the substance does not require classification as skin irritant.