4-methyl-3-decen-5-ol

Endpoint summary

Description of key information

Key study skin irritation: Arcelin (2000), OECD 404 and EU Method B.4: Not irritating.
Key study eye irritation: Anonymous (1980) an adaptation of the Draize (1955) method equivalent to OECD 405 and EU Method B.5: Not irritating (Rabbit)

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

8th August 2000 to 5th September 2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Source: Elevage Scientifique des Dombes, F-01400 Chatillon sur Chalaronne, France- Age at study initiation: 14 weeks (males) and 15 weeks (females)- Weight at study initiation: 2.7 - 2.9 kg- Housing: Individually in stainless steel cages- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum, batch no. 30/00, provided by Provimi Kliba AG, CH-4303 Kaiseraugst. Haysticks, QS n. 137/00, provided by Eberle Nafag AG, CH-9200 Gossau- Water (e.g. ad libitum): Tap water from Füllinsdorf, ad libitum- Acclimation period: 6 days under laboratory conditionsENVIRONMENTAL CONDITIONS- Temperature (°C): 21 - 23.5 °C- Humidity (%): 44 - 79 %- Air changes (per hr): 10 - 15 charges per hour- Photoperiod (hrs dark / hrs light): 12 hrs light and 12 hours dark.

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL- Amount(s) applied (volume or weight with unit): Single dose of 0.5 mL

Duration of treatment / exposure:

Duration of exposure: 4 hours

Observation period:

A total of 21 days at the following time points: 1, 24, 48 and 72 hours and 7, 10, 14, 17 and 21 days.

Number of animals:

1 male and 2 females

Details on study design:

TEST SITE- Area of exposure: 6 cm² (2.5 x 2.5 cm)- Type of wrap if used: Approximately 6 cm² of surgical gauze, covered with a semi-occlusive dressing, which was wrapped around the abdomen and anchored with tape.REMOVAL OF TEST SUBSTANCE- Washing (if done): Yes with lukewarm tap water.- Time after start of exposure: 4 hours post application.OBSERVATIONS:Mortality/Viability - Daily until termination of the test.Clinical Signs - Daily until termination of the test.Body weight - At the start of acclimatisation, day of application and at termination of the test.No necropsy was performed.

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 21 days

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.56

Max. score:

4

Reversibility:

fully reversible within: 21 days

Irritant / corrosive response data:

Irritation scores were calculated as a mean of the three animals over the three time point 24, 48 and 72 hours for both erythema and oedema.Slight scaling was observed in all animals at day 7 all were recoved by day 21

Other effects:

Mortality - none occurred.Clinical Signs - no systemic signs of toxicity.Body Weight - all rabbits were considered to be within the normal range of variability.Colouration - no staining to the skin was observed.Corrosion - no irreversible alterations of the treated skin were observed nor were corrosion effects evident on the skin.

Table 2. Individual Skin Irritation Scores.

Animal	Sex	Evaluation Interval	Erythema	Oedema	Cumulative		Scaling
					Score	Mean
73	M	1 hour	2	2	4	3.33	0
74	F		2	1	3		0
75	F		2	1	3		0
73	M	24 hours	2	1	3	3.00	0
74	F		2	1	3		0
75	F		2	1	3		0
73	M	48 hours	1	1	2	2.00	0
74	F		2	1	3		0
75	F		1	0	1		1
73	M	72 hours	1	0	1	0.67	0
74	F		1	0	1		0
75	F		0	0	0		1
73	M	7 days	0	0	0	0.00	2
74	F		0	0	0		1
75	F		0	0	0		1
73	M	10 days	0	0	0	0.00	1
74	F		0	0	0		1
75	F		0	0	0		0
73	M	14 days	0	0	0	0.00	0
74	F		0	0	0		1
75	F		0	0	0		0
73	M	17 days	0	0	0	0.00	0
74	F		0	0	0		1
75	F		0	0	0		0
73	M	21 days	0	0	0	0.00	0
74	F		0	0	0		0
75	F		0	0	0		0

 

Table 3. Mean Skin Irritation Scores After 48 and 72 Hours.

Animal	Sex	Erythema	Oedema
73	M	1.33	0.67
74	F	1.67	0.67
75	F	1.00	0.33
Mean		1.33	0.56

Interpretation of results:

not irritating

Remarks:

Migrated informationCriteria used for interpretation of results: EU

Conclusions:

The test material was determined to be not irritating. Slight erythema (1.33) and oedema (0.56) were observed, however the effects were not severe enough to trigger a classification and all effects were fully reversible within 21 days.

Executive summary:

In a GLP compliant skin irritation study, performed to standardised guidelines OECD 404 and EU method B.4 the irritation potential of the test material was determined in a 4 hour semi-occlusive test. Three rabbits were exposed to 0.5 mL of the unchanged test material for a duration of 4 hours and observed for 21 days. The mean scores from observation at 24, 48 and 72 hours were used to determine a classification. Slight erythema 1.33 and oedema 0.56 were observed, however, the effects were not severe and were fully reverse within 21 days. Under the conditions of the test, the test material was determined to be not irritating, and no classification is required under Regulation 1272/2008.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Not reported

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: A non-GLP study performed to sound scientific principles with a sufficient level of detail to assess the quality of the submitted data.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

3 concentrations were used to determine the minimal irritating and the maximal non-irritating dose. The top dose employed was 100 %

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

3 concentrations were used to determine the minimal irritating and the maximal non-irritating dose. The top dose employed was 100 %

Principles of method if other than guideline:

Adaptation of the Draize (1955) method.

GLP compliance:

no

Species:

rabbit

Strain:

other: no data

Vehicle:

unchanged (no vehicle)

Remarks:

Diethyl Phthalate or unchanged

Controls:

no

Amount / concentration applied:

TEST MATERIAL:- Amount(s) applied (volume or weight with unit): 0.1mL of the test material applied to one eye (the untreated eye served as the control)- Concentration (if solution): 100, 30 and 10 %.- Dilutions were made in Diethyl Phthalate.

Observation period (in vivo):

The observation period was 14 days at the following time points: 0, 1, 24, 48, 72 hours and day 7 and 14.

Number of animals or in vitro replicates:

3 rabbits per concentration.

Details on study design:

REMOVAL OF TEST SUBSTANCE- Washing: NoSCORING SYSTEM:- Draize scale (1977).

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: 100 % concentration

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: 100 % concentration

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

2.34

Max. score:

7

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: 100 % concentration

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0.66

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: 100 % concentration

Irritant / corrosive response data:

Scores were calculated as means of three animals as an average of 24, 48 and 72 hours.

Table 2. Irritation Reading From Application of Test Material at 100 %

			1 hour			24 hours			48 hours			72 hous			7 days			14 days
		Animal No.	1	2	3	1	2	3	1	2	3	1	2	3	1	2	3	1	2	3
Observation		Concentration
CORNEA	Opacity	100%	0	0	1	0	0	1	0	0	1	0	0	1	0	0	0	0	0	0
	Area of Opacity		0	0	0	0	0	3	0	0	1	0	0	1	0	0	0	0	0	0
	Ulceration		0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	Stain retention		0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
IRIS			0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
CONJUNCTIVA	Redness		2	2	2	2	2	2	2	2	2	1	1	1	0	0	0	0	0	0
	Chemosis		1	1	1	1	1	1	1	1	1	0	0	0	0	0	0	0	0	0
	Ulceration		0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
DISCHARGE			1	1	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Interpretation of results:

not classified

Remarks:

Migrated informationCriteria used for interpretation of results: EU

Conclusions:

The test material was determined to be unclassified for eye irritation. Application of the undiluted test material caused moderate conjunctival irritation and corneal opacity which only lasted 3 days, however these effects are not severe enough to require classification under Regulation 1272/2008.

Executive summary:

In a non GLP compliant study the eye irritation of the test material was determined according to an adapted Draize method. Three rabbits were exposed to the neat test material and dilutions of 10 and 30 %. The effects were observed over 14 days and scored according to the Draize scale. In the case of the undiluted application, conjunctival redness, slight chemosis and corneal opacity were observed, however these effects only lasted 3 days. The effects seen as a result of exposure to the test material are not severe enough to require classification under Regulation 1272/2008.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Justification for selection of skin irritation / corrosion endpoint:
The key study Arcelin (2000) was submitted to fulfil the data requirements of this endpoint. The study was performed to GLP and in line with the standardised guidelines OECD 404 and EU Method B.4. The study was performed to a good standard and was assigned a reliability score of 1, in accordance with Klimisch (1997). Under the conditions of the test, the test material was determined to be non-irritating.

Justification for selection of eye irritation endpoint:
The key study Anonymous (1980) was submitted to fulfil the data requirements of this endpoint. The study was performed according to an adaption of the Draize (1955) method which was equivalent to current guideline OECD 405 and EU Method B.5. The study was performed to a good standard and was assigned a reliability score of 2, in accordance with Klimisch (1997). Under the conditions of the test, the test material was determined to be non-irritating.

Justification for classification or non-classification

According to the criteria outlined in Regulation 1272/2008 and Directive 67/548/EEC, the test material does not meet the criteria for classification for skin or eye irritation.