Reaction Mass of 2,6-dimethyloct-7-en-2-ol and 2,6-dimethyloct-7-en-2-yl formate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

The observation period was only 7 days.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction Mass of 2,6-dimethyloct-7-en-2-ol and 2,6-dimethyloct-7-en-2-yl formate

EC Number:

915-335-6

Molecular formula:

C11H20O2 C10H20O

IUPAC Name:

Reaction Mass of 2,6-dimethyloct-7-en-2-ol and 2,6-dimethyloct-7-en-2-yl formate

Test material form:

liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Animals:
Healthy female New Zealand White rabbits were obtained from A. Smith, Warlingham, Surrey, England and were delivered on 18 February 1986. On arrival, animals were identified by tattoo in the ear with an individual unique number. Animals were permitted an acclimatisation period of 7 days before testing commenced.

Environment:
Animals were individually housed in anodised aluminum cages with grid floors and no bedding materials were provided in the cages. The animal room was air-conditioned with the temperature maintained within the range of 18-24°C and relative humidity within the range of 40-67%. Artificial lighting was by fluorescent tubes and was set to a daily cycle of 12 hours light/12 hours dark.

Diet:
All animals were fed ad libitum a commercially available pelleted rabbit diet (Product Ref. 680, Dalgety-Spillers Ltd.). Tap water was available at all times via automatic drinking nozzles in each cage.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

other: Undiluted or as 50% solution in DEP

Controls:

no

Amount / concentration applied:

A 0.5 ml aliquot of the test material was placed evenly over a 2.5 cm square of surgical lint B.P. The lint square was then placed onto the animals skin, on the left flank and immediately caudal to the last rib, with the test material in contact with the skin. In the test, a second test material was applied in the same manner to the right flank. Lint patches were held in place with Elastoplast bandages (10 cm wide). The test material was applied a group of four animals either neat (undiluted) or as a 50% solution.

Duration of treatment / exposure:

After a period of 4 hours, the adhesive tapes was removed and the treated sites cleansed by gently swabbing with cotton wool soaked in warm water.

Observation period:

One hour after removal and at 4, 24, 48, 72 and 168 hours after patch removal, animals were assessed for signs of reaction to treatment. Animals were examined under a standard light source designed to comply with the requirements of B.S. 950 Part 1 (Artificial Daylight for the Assessment of Colour). Irritation was assessed as described in the guideline.

Number of animals:

4

Details on study design:

The day before treatment, rabbits were restrained and the dorsal surfaces of the trunk clipped free of hair using a Oster Model A2 clipper with Angra blade. Groups of 4 healthy animals with intact skin were selected for the study.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: Animal 1

Results 2

Irritation parameter:

erythema score

Basis:

animal: #2, 3, and 4

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Remarks on result:

other: Animal 2, 3, and 4

Results 3

Irritation parameter:

edema score

Basis:

animal: #1, 3, and 4

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Remarks on result:

other: Animal 1, 3, and 4

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.67

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Remarks on result:

other: Animal 2

Irritant / corrosive response data:

Sample 8A (50% Dimyrcetol, See Table 1): Well defined erythema and very slight oedema of the skin were apparent in 3/4 rabbits and very slight erythema in 1/4 rabbits 1 hour after dosing. Some increase in severity of oedematous response was exhibited by 2/4 animals at 24 hours, with slight reaction observed. Further increases in response were apparent at the 48 hour examination with well defined erythema noted in all 4 rabbits. Oedema of the skin ranged from very slight in one rabbit, slight in two rabbits, and moderate in one rabbit. Slight desquamation of the surface of treated skin was also observed in one rabbit. The irritant response seen in one rabbit had declined by the 72 hour observation, with very slight erythema remaining. There were no remaining reactions at treated sites on any rabbit by day 7 after dosing.

Sample 8B (100% Dimyrcetol, See Table 2): Well defined erythema was observed in all 4 rabbits and very slight oedema of the treated skin in three rabbits was apparent at the one hour observation. Oedematous responses increased and at 24 hours after dosing slight reaction was observed in three rabbits and very slight reaction was noted in the remaining rabbit of the group. Well defined erythema and slight oedema were present at the treated site of all four rabbits 48 and 72 hours after dosing. This response had declined within 7 days with very slight erythema remaining in 3 rabbits and very slight oedema in all 4 rabbits. Slight desquamation from the treated skin was also observed in one rabbit.

Any other information on results incl. tables

Table 1: Sample 8A Results

Rabbit No. /Observation Time	Erythema Score	Oedema Score	Comments
909
1 hour	2	1
24 hour	2	2
48 hour	2	3
72 hour	2	3
168 hour	0	0
914
1 hour	1	0
24 hour	1	0
48 hour	2	1	Slight desquamation
72 hour	1	0	Very slight desquamation
168 hour	0	0
915
1 hour	2	1
24 hour	2	1
48 hour	2	2
72 hour	2	2
168 hour	0	0
917
1 hour	2	1
24 hour	2	2
48 hour	2	2
72 hour	2	2
168 hour	0	0

Table 2: Sample 8B Results

Rabbit No. /Observation Time	Erythema Score	Oedema Score	Comments
909
1 hour	2	0
24 hour	2	2
48 hour	2	2
72 hour	2	2
168 hour	0	1
914
1 hour	2	1
24 hour	2	1
48 hour	2	2
72 hour	2	2
168 hour	1	1	Slight desquamation
915
1 hour	2	1
24 hour	2	2
48 hour	2	2
72 hour	2	2
168 hour	1	1
917
1 hour	2	1
24 hour	2	2
48 hour	2	2
72 hour	2	2
168 hour	1	1

Applicant's summary and conclusion

Interpretation of results:

other: Not a skin irritant

Remarks:

according to EU CLP (EC 1272/2008 and its amendments)

Conclusions:

An in vivo skin irritation test was conducted similar to OECD 404 and following GLP principles. The test material needs to be classified as Skin Mild Irrit 3 (H316) according to GHS.

Executive summary:

In a skin irritation study, performed similar to OECD 404 and following GLP principles, four female New Zealand white rabbits were exposed to 0.5 ml of undiluted test material and 0.5 of a 50% solution under semi-occlusive conditions. After 4 hours, the test substance was removed by gentle swabbing with cotton wool soaked in warm water, and animals were observed for 7 days. Following 4-hour treatment with the undiluted material, the mean erythema scores of the four rabbits were 2 for all rabbits (mean scores 24, 48, and 72 hours after removal of the substance). The mean oedema scores over this time period were 2, 1.67, 2, and 2, respectively. Most of the effects were not reversible within 7 days. Based on the edema and erythema scores being <2.3, the substance is considered to be not an irritant.