Butyl decanoate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

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

Adequacy of study:

key study

Justification for type of information:

refer to analogue justification provided in IUCLID section 13

Cross-reference

Reason / purpose for cross-reference:

read-across source

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

31 Mar - 10 Apr 1992

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

no data on analytical purity of the test item were given

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

analytical purity of test substance not specified

GLP compliance:

yes

Species:

rabbit

Strain:

other: Kleinrussen, Chbb:HM

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Thomae GmbH, Biberach, Germany
- Weight at study initiation: mean 2460 g
- Housing: individually
- Diet: Ssniff rabbit diet K4, ad libitum
- Water: ad libitum
- Acclimation period: at least 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 25
- Humidity (%): 45 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:

24 h

Observation period (in vivo):

72 h
Reading time points: 1, 24, 48 and 72 h

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE: rinsing with tap water after the 24 h exposure period

SCORING SYSTEM: according to the council directive 84/449/EEC (Draize scoring system)

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritation parameter:

iris score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: redness graded 1 was seen at reading time points 1 and 24 h.

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: not applicable

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: not applicable

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

Slight erythema was observed in one animal at reading time points 1 and 24 hours; at time point 1 hour only, the finding was further accompanied by lacrimation graded 2. In a further animal, slight erythema of grade 1 and lacrimation of grade 2 were reported for the 1 hour reading time point only. The third animal only showed lacrimation graded 2 at reading time point 1 hour.

Table 1: Individual evaluation of the eye lesions for time points 24, 48 and 72 hours

Animal No.	Hours after application
	24					48					72
	A	B	C	D	L	A	B	C	D	L	A	B	C	D	L
1	0	0	1	0	0	0	0	1	0	0	0	0	0	0	0
2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	-
3	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

A = Cornea Score

B = Iris Score

C = Erythema Score

D = Chemosis Score

L = Lacrimation

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008

Conclusions:

CLP: not classified

Materials and methods

Test material

Test material information

Constituent 1

Reference substance name:

Butyl decanoate

EC Number:

250-280-5

EC Name:

Butyl decanoate

Cas Number:

30673-36-0

Molecular formula:

C14H28O2

IUPAC Name:

butyl decanoate

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: Source: CAS 111-82-0

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Remarks on result:

other: Source: CAS 111-82-0

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: redness graded 1 was seen at reading time points 1 and 24 h.

Remarks:

Source: CAS 111-82-0

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: not applicable

Remarks on result:

other: Source: CAS 111-82-0

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: not applicable

Remarks on result:

other: Source: CAS 111-82-0

Results 6

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: Source: CAS 111-82-0

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008

Conclusions:

Based on the in vivo eye irritation study with the source substance no eye irritation potential was observed. As explained in the analogue justification, this result is considered to be valid also for the target substance.