[No public or meaningful name is available]

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

GLP compliant

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

4-Cyclohexan-1-ol, dodecyl-, branched

EC Number:

938-702-2

Molecular formula:

not applicable UVCB

IUPAC Name:

4-Cyclohexan-1-ol, dodecyl-, branched

Details on test material:

- Storage condition of test material: room temperature in a closed container
- Name of test material (as cited in study report): Cyclohexanol, 4-C11-12-alkyl, branched
- Molecular weight (if other than submission substance): 267-280 g/mol
- Physical state: liquid
- Analytical purity: 95.8 %
- Lot/batch No.: 04152/MA
- Expiration date of the lot/batch: May 2014
- Storage condition of test material: room temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH, 97633 Sulzfeld, Germany
- Age at study initiation: approximately 14-15 weeks old
- Weight at study initiation: > 2 kg
- Housing: individually housed in ABS-plastic rabbit cages, floor 4200 cm²
- Diet (e.g. ad libitum): Altromin 2123 maintenance diet for rabbits (lot no 0650), rich in crude fibre, ad libitum
- Water (e.g. ad libitum): tap water (drinking water, municipal residue control, microbiological controls at regular intervals) ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 2012-09-09 To: 2012-10-31

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: The untreated other side served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL per test site

Duration of treatment / exposure:

4 hours

Observation period:

up to 72 hours after patch removal

Number of animals:

3 females

Details on study design:

TEST SITE
- Area of exposure: approx. 6 cm² of shaved skin on one side of the dorsal area
- % coverage: not mentioned
- Type of wrap if used: gauze patch, which was held in place with non-irritating tape


REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, the residual test item was removed with tap water
- Time after start of exposure: 4 hours


SCORING SYSTEM: according to guideline

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

1.9

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0.8

Max. score:

4

Irritant / corrosive response data:

Under the conditions of the present study, the single dermal application of the test item to three rabbits at a dose of 0.5 mL showed irritant effects, which were not fully reversible within the observation period in two of three animals.

Animal No. 1: 14 days after patch removal erythema grade 1.

Animal No. 3 showed after 14 days time after Patch Removal extensive desquamation.

Animal No. 2: The changes were fully reversible within 4 days after patch removal.


Animal No. 1: Erythema: grade 2 after 1, 24, 48 hours, 4, 5, 6, 7 days, grade 1: until 14 days
Edema: grade 1 after 1, 24, 48, 72 hours, grade 2 after 4 days, grade 1 after 5, 6, 7, 8 days and then they were fully reversible

Animial No. 2: Erythema: grade 1 after 1, 24, 48, 72 hours and then they were fully reversible
Edema: none

Animal No. 3: Erythema: grade 1 after 1 hour, grade 2 after 24 hours, grade 3 after 48, 72 hours, 4 days, grade 2 after 5 days, grade 1 after 6 and 7 days and then they were fully reversible
Edema: nothing after 1 hour, grade 1 after 24 hours, grade 2 after 48 hours, grade 1 after 72 h, 4, 5, 6 days and then they were fully reversible.

Animal No. 1 showed after 4 until 9 days desquamation. On the other time intervals not.
Animal No. 2 showed no specific findings.
Animal No. 3 showed after 5 until the end of the observation period extensive desquamation.

Other effects:

There were no significant body weight changes during the contact and observation period.

Any other information on results incl. tables

Table #: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility	Erythema	Edema	Specific local findings (apart from erythema/oedema)*)
	Max. score: 4	Max. score: 2
60 min	2/1/1	1/0/0	nsf/nsf/nsf
24 h	2/1/2	1/0/1	nsf/nsf/nsf
48 h	2/1/3	1/0/2	nsf/nsf/nsf
72 h	2/1/3	1/0/1	nsf/nsf/nsf
day 4	2/0/3	0/0/0	des./nsf/nsf
day 5	2/-/2	1/-/1	des./-/ext.des.
day 6	2/-/1	1/-/1	des./-/ext.des.
day 7	2/-/1	1/-/0	des./-/ext.des.
day 8	1/-/0	1/-/0	des./-/ext.des.
day 9	1/-/0	0/-/0	des./-/ext.des.
day 10	1/-/0	0/-/0	nsf/-/ext.des.
day 11
day 12
day 13
day 14
Average 24h, 48h, 72h
Reversibility**)
Average tine for reversion

 

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

 

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

Under the conditions of the present study, the single dermal application of the test item to three rabbits at a dose of 0.5 mL showed irritant effects, which were not fully reversible within the observation period in two of three animals. One animal showed at the end of the observation time of 14 days erythema grade 1, one animal showed after 14 days extensive desquamation. The total mean value irritation scores (mean 24-72 hours) were 1.9 (erythema) and 0.8 (edema).

Executive summary:

Under the conditions of the present study, the single dermal application of the test item to three rabbits at a dose of 0.5 mL showed irritant effects, which were not fully reversible within the observation period in two of three animals. Therefore the substance Cyclohexanol, 4 -C11 -12 -alkyl, branched is an skin irritant Category 2 and has the H-Phrase H315 .