Registration Dossier

Administrative data

Endpoint:
skin irritation: 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-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
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

Reference
Name:
Unnamed
Type:
Constituent
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 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

Resultsopen allclose all
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
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
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
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
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
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.