3,7,11-Trimethyldodec-1-en-3-ol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

October 2001

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

HETCAM-Test used for detecting severe eye irritation in hen's eggs.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

3,7,11-trimethyldodec-1-en-3-ol

EC Number:

609-221-2

Cas Number:

3625-46-5

Molecular formula:

C15H30O

IUPAC Name:

3,7,11-trimethyldodec-1-en-3-ol

Test material form:

liquid

Details on test material:

Tetrahydronerolidol (THNER)
CAS No. 3625-46-5
Batch No.: Anlage 067, 13 Jun 2001
Purity: 96 %

Test animals / tissue source

Species:

other: chorioallantoic membrane of hen's eggs (HET-CAM) Test

Test system

Vehicle:

other: olive oil Ph.Eur./DAB

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

undiluted and 10% in solution

Duration of treatment / exposure:

5 minute(s)

Number of animals or in vitro replicates:

3

Results and discussion

In vitro

Results

Irritation parameter:

in vitro irritation score

Run / experiment:

1

Value:

0

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: No indication of severe irritation

Other effects / acceptance of results:

After five minutes, no appearance of haemorrhagia, lysis and/or coagulation was found.

Any other information on results incl. tables

Table 1: Results of the undiluted test substance in the HETCAM Test

Concentration	Egg-No.	Time (seconds) until appearance of:			Index for irritation
		Haemorrhagia	Lysis	Coagulation
Undiluted test substance	1	301.0	301.0	301.0	0.0
	2	301.0	301.0	301.0	0.0
	3	301.0	301.0	301.0	0.0
Mean	n =3	301.0	301.0	301.0	0.0

Table 2: Results of the 10% diluted test substance in the HETCAM Test

Concentration	Egg-No.	Time (seconds) until appearance of:			Index for irritation
		Haemorrhagia	Lysis	Coagulation
Test substance 10% in olive oil Ph.Eur./DAB	1	301.0	301.0	301.0	0.0
	2	301.0	301.0	301.0	0.0
	3	301.0	301.0	301.0	0.0
Mean	n =3	301.0	301.0	301.0	0.0

Table 3: Results of the positive control (0.1 N NaOH)

Concentration	Egg-No.	Time (seconds) until appearance of:			Index for irritation
		Haemorrhagia	Lysis	Coagulation
0.1 N NaOH	1	23	301.0	45	12.3
	2	23	301.0	46	12.3
Mean	n =2	23.0	301.0	45.5	12.3

Table 4: Results of the positive control 1% SDS

Concentration	Egg-No.	Time (seconds) until appearance of:			Index for irritation
		Haemorrhagia	Lysis	Coagulation
1 % SDS	1	35	301.0	73	11.3
	2	62	301.0	86	10.4
	3	39	301.0	66	11.4
Mean	n =3	45.3	301.0	75.0	11.0

n = number of eggs

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Conclusions:

The test substance did not show any effect on the egg shells and thus, it was concluded that there is no risk of serious damage to the eyes. However, possible eye irritancy cannot be evaluated in this test system.

Executive summary:

The HETCAM-Test was used to assess the potential of the test substance to induce severe eye irritation at concentrations of 100% (undiluted) and 10% (test substance 10% in olive oil Ph.Eur./DAB) on the chorioallantoic membrane of hen's eggs. Three eggs per concentration were used and the appearance of haemorrhagia, lysis and/or coagulation was observed after 301 seconds post-treatment at both concentrations used. Thus, the index for irritation was set to 0.0.