3,7-dimethylnona-2,6-dienenitrile

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

October 25, 1988 - October 28, 1988

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Study performed according to GLP and OECD Guideline READ ACROSS To address toxicological endpoints as part of the REACH registration of Lemonile (Target Substance) it is proposed to read-across to Citronellyl Nitrile (Source Substance). The use of read-across works within the spirit of REACH and the stated aim of the legislation to reduce animal testing where possible. The Target Substance and Source Substance have been characterised in using the categories and databases present in the OECD [Q]SAR Toolbox. From the profiling in this table, it can be seen that the two substances share structural similarities and also ‘mechanistic action’ similarities which are both general and endpoint specific. Therefore read across is justified.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

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:

88-214-01

IUPAC Name:

88-214-01

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report):88-214-01
- Physical state: Liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hazleton Research Products, Inc. Denver, PA
- Weight at study initiation: Refer to Table 3 in results section
- Housing: Rabbits were housed individually in cages sized in accordance with the " Guide for the Care and Use of Laboratory Animals" of the Institute of Laboratory Resources, National Research Council.
- Diet: Wayne Rabbit Ration ad libitum
- Water: Fresh tap water ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 °C ± 3°C
- Humidity: 30 to 70%:
- Photoperiod: 12 hrs dark / 12 hrs light

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: intact

Amount / concentration applied:

0.5 ml

Duration of treatment / exposure:

72 h

Number of animals:

Four (two males and two females)

Details on study design:

TEST SITE
Test article was administered at one intact site on the dorsal trunk of the animal. Approximately 24 hours prior to the study, all application sites were clipped free of hair. Flowwing the application of the test material, gauze patches were applied to each of the sites then wrapped with a rubber dam and an Ace bandage to retard evaporation.

SCORING SYSTEM:
After patch removal the animals were examined for erythema and edema and scored according to Draize at 30-60 minutes, 24, 48 and 72 hours after patch removal

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.67

Results 4

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0.33

Results 5

Irritation parameter:

erythema score

Basis:

mean

Remarks:

All animals

Time point:

24/48/72 h

Score:

0.5

Results 6

Irritation parameter:

edema score

Basis:

animal: # 1,2 3 and 4

Time point:

24/48/72 h

Score:

0

Irritant / corrosive response data:

The pH of the test article was 6. No signs of irritation or corrosion were observed at the 30-60 minute post-dose observation period. Very slight to well-defined erythema was observed in three animals at the 24 hour observation period. Very slight erythema was observed in two animals at the 48 hour observation period. No signs of edema were observed during the study. All scores returned to normal at the 72 hour post-dose observation period and the study was terminated.

Any other information on results incl. tables

Table 1: Dermal irritation observations

Rabbit number	Sex	Observations/post treatment
		30-60 minutes		24 hours
		Erythema	Edema	Erythema	Edema
8596	♂	0	0	0	0
8597	♂	0	0	2	0
8598	♀	0	0	1	0
8599	♀	0	0	1	0

Table 2: Dermal irritaiton observations

Rabbit number	Sex	Observations/post treatment
		48 hours		72 hours
		Erythema	Edema	Erythema	Edema
8596	♂	0	0	0	0
8597	♂	1	0	0	0
8598	♀	1	0	0	0
8599	♀	0	0	0	0

Table 3: Weight (kg)

Rabbit number	Sex	Initial	Final
8596	♂	3.709	3.853
8597	♂	3.277	3.403
8598	♀	3.273	3.387
8599	♀	3.830	3.890

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The substance is not considered to be irritating to skin according to CLP Regulation (EC) no. 1272/2008.