1-[(2-tert-butylcyclohexyl)oxy]butan-2-ol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion, other

Remarks:

in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 11 to 15 December 1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study with no restriction.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes

Test material

Test material information

Constituent 1

Details on test material:

- Name of test material (as cited in study report): 1-(2-tert-butyl cyclohexyloxy)-2-butanol cited as P#620

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Froxfield Ltd., Petersfield, Hampshire, UK
- Age at study initiation: 10 to 11 weeks
- Weight at study initiation: 2.2 to 2.5 kg
- Housing: housed individually in metal cages with perforated floors
- Diet (e.g. ad libitum): standard diet SDS Stanrab (P), ad libitum
- Water (e.g. ad libitum): drinking water, ad libitum
- Acclimation period: yes

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C
- Humidity (%): 30-70%
- Air changes (per hr): 19 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hrs dark, 12 hrs light

IN-LIFE DATES: From: To: no data

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.5 mL
- Concentration (if solution): not applicable

VEHICLE
Not applicable

Duration of treatment / exposure:

4 h

Observation period:

30 min after removal of the dressing, 24, 48, 72 and 96 hours after exposure.

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: dorso-lumbar region
- % coverage: 6.25 cm2
- Type of wrap if used: "Elastoplast" elastic adhesive dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with warm water at 30 to 40°C. Then, the treated area was blotted dry with absorbent paper.
- Time after start of exposure: 4h

SCORING SYSTEM: Draize scale according to OECD guideline No. 404

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

mean individual score

Time point:

other: overall at 24, 48 and 72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 4 days

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

mean individual score

Time point:

other: overall at 24, 48 and 72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 4 days

Remarks on result:

other: Dryness and sloughing of the epidermis at 24, 48 and 72h

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

mean individual score

Time point:

other: overall at 24, 48 and 72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 4 days

Remarks on result:

other: Dryness and sloughing of the epidermis at 48 and 72h

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

mean individual score

Time point:

other: overall at 24, 48 and 72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 2 days

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

mean individual score

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

mean individual score

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

Very slight to well defined erythema with or without slight oedema was observed in all rabbits.
Dryness and sloughing of the epidermis was observed in 2 rabbits between 24 and 48 hours.
All reactions had resolved by 96 hours.

Other effects:

There were no signs of toxicity or ill health in any rabbit.


Dryness and sloughing of the epidermis was observed in two
rabbits between Day 2 and 4. All reactions had resolved by
Days 5.


There were no signs of toxicity or ill health in any rabbit
during the observation period.

Any other information on results incl. tables

Table 7.3.1/1:Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test (4h)

Score at time point / Reversibility	Erythema	Edema
	Max. score: 4	Max. score: 4
30 min	2/1/2	1/1/1
24 h	1/1/1	1/0/0
48 h	1/1/1	0/0/0
72 h	1/1/1	0/0/0
Average 24h, 48h, 72h	1/1/1	0.3/0.0/0.0
Reversibility*)	c	c
Average time (day) for reversion**	4 days	2 days

 *) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

**): correspond to the last day for which skin irritation signs in the last animal were observed

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the test conditions, the test item P#620 induced a slight reversible irritation of the skin but no classification as skin irritant is required according to the Annex VI of the Regulation (EC) No 1272/2008 (CLP) and the Annex VI of the Directive 67/548/EC.

Executive summary:

In a dermal irritation study performed according to the OECD guideline No. 404, an in compliance with the GLP, 0.5 mL of undiluted P#620 (purity of 89.01%) was dermally applied on the shaved skin of the dorso-lumbar region of 3 New Zealand White rabbits.Test sites were covered with a semi-occlusive dressing for 4 hours. Animals were then observed for 4 days for edema and erythema. 

Skin irritation was assessed and scored according to the Draize scale at 30 min, 24, 48 and 72 hrs after the removal of the patch.  

The mean individual scores calculated within 3 scoring times (24, 48 and 72 hrs) were 1/1/1 for erythema and 0.3/0.0/0.0 for edema.

Under the test conditions, the test item P#620 induced a slight reversible irritation of the skin but no classification as skin irritant is required according to the Annex VI of the Regulation (EC) No 1272/2008 (CLP) and the Annex VI of the Directive 67/548/EC.

This study is considered as acceptable and satisfies the requirement for skin irritation endpoint.