Guerbet alcohols, C24-26, branched and cyclic

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

Justification for type of information:

The study was performed for the notification in other regions where authorities do not accept read-across nor in vitro data.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Guerbet alcohols, C24-26, branched and cyclic

EC Number:

942-520-9

Cas Number:

2041102-78-5

Molecular formula:

not applicable, UVCB

IUPAC Name:

Guerbet alcohols, C24-26, branched and cyclic

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): Isofol 2426 S
- Substance type: pure active substance
- Physical state: colourless liquid
- Storage condition of test material: room temperature: 20 ± 5 °C

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: laboratory breed, EUROLAP (F-35140 GOSNE)
- Age at study initiation: 9 or 12 weeks old
- Housing: single housing
- Diet (e.g. ad libitum): SAFE - 112, ad libitum
- Water (e.g. ad libitum): Drinking water ad libitum
- Acclimation period: minimum 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23
- Humidity (%): 30 to 70
- Air changes (per hr): at least 10 per hour
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml per kg bw was applied undiluted

Duration of treatment / exposure:

4 hours

Observation period:

1 hour, and then 24, 48 and 72 hours aftter patch removal

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 6 cm² of shaved skin of the dorsal and lateral parts of the trunk of the animals
- coverage: patch (25 mm x 25 mm) non woven swab of 4.layer (MEDISTOCK)
- Type of wrap if used: sugical adhesive tape (50 mm wide hypoallergienic micropore adhesive tape from 3M)

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 4 hours

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48 and 72 hours after patch removal

Score:

ca. 1.33

Max. score:

2

Reversibility:

fully reversible within: 7 or 14 days

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48 and 72 after patch removal

Score:

0

Max. score:

0

Results 3

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

1

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 14 days

Results 5

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7 days

Results 6

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 7

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 8

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritant / corrosive response data:

A very slight to well defied erythema was noted on the treated area 24 hours after patch removal in all animals which was totally reversible between 7 and 14 days.

Other effects:

On the cutaneous structure, dryness of the skin was noted in one animal on day 3 and in a second animal on day 7. The skin recovered to a normal aspect on day 14.

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for each animal at each observation time point

Score at time point / Reversibility	Erythema	Edema
	Max. score: 4	Max. score: 2
1 h	0/1/1	0/0/0
24 h	1/2/1	0/0/0
48 h	1/2/1	0/0/0
72 h	1/2/1	0/0/0
Day 7	0/1/0	0/0/0
Day 14	0/0/0	0/0/0
Average 24h, 48h, 72h	1.33	0
Reversibility*)	c	-

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

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the results of this study, the substance Guerbet alcohols, C24-26, branched and cyclic is slightly irritating to the skin.

Executive summary:

An acute dermal irritation study was conducted on 3 New Zealand rabbits accoidn to OEECD Test Guideline 404. 0.5 ml of the test substace Guerbet alcohols, C24 -26, branched and cyclic were applied to the undamaged skin of the animals under semioccusive conditions for 4 hours. A very slight to well defied erythema was noted on the treated area 24 hours after patch removal in all animals which was totally reversible between 7 and 14 days. Based on the results of this study, the substance Guerbet alcohols, C24-26, branched and cyclic is slightly irritating to the skin.