Reaction mass of 3,7-dimethyl-1-octyl acetate and citronellyl acetate

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 in vivo test was performed before the REACH regulation came into force, requesting in vitro studies. This information is used for read-across to Citronellyl Acetate Multi

Cross-reference

Reason / purpose for cross-reference:

read-across: supporting information

Reference

Endpoint:

skin irritation: in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

2018

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Read-across information.

Justification for type of information:

The read-across justification is presented in the Endpoint summary Irritation. The accompanying files are also attached there.

Reason / purpose for cross-reference:

read-across source

Irritation parameter:

erythema score

Basis:

mean

Remarks:

all animals tested

Time point:

24/48/72 h

Score:

2.5

Max. score:

4

Reversibility:

fully reversible within: 15 days

Irritation parameter:

edema score

Basis:

mean

Remarks:

all animals tested

Time point:

24/48/72 h

Score:

0.8

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Interpretation of results:

other: Skin irritant Cat. 2

Remarks:

according to Regulation (EC) No. 1272/2008 and its amendments.

Conclusions:

The mean erythema score (24 -72 hours) per animal was 3, 2.3 and 2.3 (highest score was 3, any erythema signs resolved on day 15), the mean edema scores were 1, 0.7 and 0.7 (any edema signs resolved at 72 hours). Scaling was observed in all animals 8 days after removal and scaling was still noted for one rabbit 15 days after removal. Based on these results from read-across, Citronellyl Acetate Multi is found to have skin irritant properties and is classified Category 2.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Citronellyl acetate

EC Number:

205-775-0

EC Name:

Citronellyl acetate

Cas Number:

150-84-5

Molecular formula:

C12H22O2

IUPAC Name:

3,7-dimethyloct-6-en-1-yl acetate

Test material form:

liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: DR. K. Thomae GmbH, Biberach
- Age at study initiation: young adult
- Animal identification: ear tattoo
- Weight at study initiation: female: 3.76 kg; male: 3.41 and 3.48 kg
- Housing: single housing, stainless stell wire mesh cages with grating, floor area: 3000 cm2
- Bedding: no bedding in the cages; sawdust in the waste trays
- Diet: Kliba-Labordiaet 341, Klingentalmuehle AG, Kaiseraugst, Switzerland (about 130 g/animal/day)
- Water: Tap Water (about 250 ml/animal/day)
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 h / 12 h

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: negative control: untreated skin of same animal

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml on intact untreated skin
- Concentration (if solution): 100%

Duration of treatment / exposure:

4 h

Observation period:

15 days

Number of animals:

3

Details on study design:

TEST SITE
- Preparation: at least 24 h before the test, the fur was removed by clipping the dorsal of the trunk of the animal; only animals with healthy/intact skin were used
- Area of exposure: upper third of back or flanks
- Application: 2.5 x 2.5 cm test patch moistened with 0.5 ml of the test substance
- Type of wrap if used: test patch (Idealbinde, Pfaelzische Verbandstoff-Fabrik, Kaiserslautern) and Fixomull(R) stretch (adheasive Fleece), Beiersdorf AG

REMOVAL OF TEST SUBSTANCE
- Washing: with Lutrol (BASF SE) and Lutrol in water (1:1)
- Time after start of exposure: 4 h

READING
- 1 h, 24 h, 48 h, 72 h, 8 d and 15 d after patch removal

OBSERVATIONS
- Check for general observations and dead or moribund animals: twice daily (Mo - Fr), once daily (Sa/Su)
SCORING SYSTEM
- According to OECD guideline 404 (adopted july 17, 1992) and EEC L 383A, B.4 (december 29, 1992)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

all animals tested

Time point:

24/48/72 h

Score:

2.5

Max. score:

4

Reversibility:

fully reversible within: 15 days

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

all animals tested

Time point:

24/48/72 h

Score:

0.8

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Any other information on results incl. tables

For calculation of the means only the 24, 48 and 72 hours readings were taken into consideration.

Irritant response data:

Readings	Animal	Exposure period: 4 h
		Erythema	Edema	Additional findings
1h	1	2	1
	2	2	1
	3	2	1
24 h	1	3	2
	2	3	1
	3	3	1
48 h	1	3	1
	2	2	1
	3	2	1
72 h	1	3	0
	2	2	0
	3	2	0
8 d	1	1	0	scaling
	2	0	0	scaling
	3	0	0	scaling
15 d	1	0	0	scaling
	2	0	0
	3	0	0
Mean 24 - 72 h	1	3	1
	2	2.3	0.7
	3	2.3	0.7
Mean		2.5	0.8

Animal 1: female; animal 2: male; animal 3: male

Applicant's summary and conclusion

Interpretation of results:

other: Skin irritant Cat. 2

Remarks:

according to EU CLP (EC No. 1272/2008, and its amendments).

Conclusions:

The mean erythema score (24 -72 hours) per animal was 3, 2.3 and 2.3 (highest score was 3, any erythema signs resolved on day 15), the mean edema scores were 1, 0.7 and 0.7 (any edema signs resolved at 72 hours). Scaling was observed in all animals 8 days after removal and scaling was still noted for one rabbit 15 days after removal. Based on these results, Citronellyl Acetate (‘mono’) is found to have skin irritant properties and is classified Category 2.

Executive summary:

An in vivo skin irritation test was performed with Citronellyl Acetate (‘mono’) according to OECD 404 and following GLP principles. Three rabbits were exposed semi-occlusively to 0.5 mL of the test substance (purity 98.8%) during 4 hours. After exposure, the sites were washed with Lutrol and Lutrol in water (1:1), skins were examined at 1 hour, 24, 48, 72 hours, 8 and 15 days after patch removal. The mean erythema score (24 -72 hours) per animal was 3, 2.3 and 2.3 (highest score was 3, any erythema signs resolved on day 15), the mean edema scores were 1, 0.7 and 0.7 (any edema signs resolved at 72 hours). Scaling was observed in all animals 8 days after removal and scaling was still noted for one rabbit 15 days after removal. Based on these results, Citronellyl Acetate (‘mono’) is found to have skin irritant properties and is classified Category 2: Irritant to the skin.