Registration Dossier

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Administrative data

Description of key information

Tetradecyl myristate (CAS No 3234 -85 -3), a constituent of the registration substance, and Octyldodecyl isostearate (CAS No 93803 -87 -3), a structural analogue of the registration substance, were tested for their skin irritant properties in New Zealand White rabbits. The studies were performed according to OECD Guideline 404.With reference the reported scores and the full reversibility of effects it is concluded that the registration substance does not have to be classified as irritant to the skin according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).

An in vivo eye irritation study in rabbits was perfromed with tetradecyl myristate (CAS No. 3234 -85 -3), a constituent of the registration substance, 2 -Ethylhexyl laurate and 2-octyldodecyl isooctadecanoate (CAS No 93803 -87 -3),

structural analogues of the registration substance. The studies were conducted according to OECD Guideline 405.

With reference the reported scores and the reversibility the registration substance does not have to be classified as irritant to the eyes according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
exposure period 24 h, occlusive conditions, no experimental 48 h reading performed, few details reported
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: not required, the untreated site of the same animal served as the control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
Duration of treatment / exposure:
24 h
Observation period:
72 h
Reading time points: 24 and 72 h
Number of animals:
6 males
Details on study design:
SCORING SYSTEM: Draize scoring system
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Remarks on result:
other: no 48 h data are available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h)
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: no 48 h data are available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h)
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Remarks on result:
other: no 48 h data are available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h)
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Remarks on result:
other: no 48 h data are available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h)
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Remarks on result:
other: no 48 h data are available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h)
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Remarks on result:
other: no 48 h data are available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h)
Irritation parameter:
edema score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Remarks on result:
other: no 48 h data are available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h)
Irritant / corrosive response data:
Intact skin:
1/6 animals had slight erythema (score 1 of 4) at the 24-hour reading time point, which had cleared completely by the 72-hour reading time point (see Table 1). No other skin irritation effects were observed in any animals.

Abraded skin:
1/6 animals had slight erythema (score 1 of 4) at the 24-hour reading time point. The skin irritation had cleared within 48 hours.

Table 1: individual erythema and edema scores for intact skin

Observation time

Rabbit No.

1

2

3

4

5

6

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

24 h

0

0

1

0

0

0

0

0

0

0

0

0

48 h

No experimental data available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption)

 

72 h

0

0

0

0

0

0

0

0

0

0

0

0

 

Table 2: calculation of mean scores for intact skin

 

Rabbit No.

1

2

3

4

5

6

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

Mean value 24+48+72 h

0

0

0.67

0

0

0

0

0

0

0

0

0

Interpretation of results:
GHS criteria not met
Conclusions:
With reference the reported scores and the full reversibility of effects within 72 h the test item does not have to be classified as irritant to the skin according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
Executive summary:

Tetradecyl myristate (CAS No 3234 -85 -3), a constituent of the registration substance, was tested for its skin irritant properties in 6 New Zealand White rabbits. The study was performed according to OECD Guideline 404.

With reference the reported scores and the full reversibility of effects within 72 h the test item does not have to be classified as irritant to the skin according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).

Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
17 - 20 Feb 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
GLP - Guideline study. According to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Please refer to cread across justification justification setcion 13.2

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
Please refer to cread across justification justification setcion 13.2

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Please refer to cread across justification justification setcion 13.2

3. ANALOGUE APPROACH JUSTIFICATION
Please refer to cread across justification justification setcion 13.2

4. DATA MATRIX
Please refer to cread across justification justification setcion 13.2
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritant / corrosive response data:
3/3 animals had well-defined erythema at the 1-hr reading time point. The erythema had reduced in severity by 24 hours after exposure in 3/3 rabbits (score 1, 1, 1), and had cleared completely within 72 hours for 3/3 rabbits. No edema was observed in any animal at any time point (see Table 1).
Other effects:
There was no mortality, and no clinical signs were observed during the study period.

Table 1: Skin irritation scores

Observation time

Rabbit no.

 

1

2

3

 

Erythema

Edema

Erythema

Edema

Erythema

Edema

 

1 h*

2

0

2

0

2

0

 

24 h

1

0

1

0

1

0

 

48 h

1

0

0

0

0

0

 

72 h

0

0

0

0

0

0

 

Mean value 24 + 48 + 72 h

0.67

0

0.33

0

0.33

0

 

 

* Greasy remnants of the test substance was present on the test site in 3/3 rabbits

Interpretation of results:
GHS criteria not met
Conclusions:
With reference the reported scores and the full reversibility of effects within 72 h the test item does not have to be classified as irritant to the skin according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
Executive summary:

Octyldodecyl isostearate (CAS No 93803 -87 -3), a structural analogue of the registration substance, was tested for its skin irritant properties in 3 New Zealand White rabbits. The study was performed according to OECD Guideline 404. With reference the reported scores and the full reversibility of effects within 72 h the test item does not have to be classified as irritant to the skin according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
; purity not reported, 50% dilution of test substance
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.8-2.4 kg
Vehicle:
other: corn oil
Controls:
other: the left eye served as the control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): 50% (w/w)

VEHICLE
- Concentration (if solution): 50% (w/w)
Duration of treatment / exposure:
Single application without washing
Observation period (in vivo):
7 days
Reading time points: 24, 48 and 72 h, and 7 days
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated eye was not washed after instillation.

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: hand-held lens
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of all 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
of all 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.66
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility not applicable
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritant / corrosive response data:
Slight redness was observed in 4/6 animals at the 24-hour reading time point, which had cleared completely within 72 hours (see Table 1). No other eye irritation effects were observed in any of the animals.

Table 1: Individual eye irritation scores

 

Rabbit #

 

Time [h]

 

conjunctivae

 

iris

 

cornea

 

 

conjunctivae

 

iris

 

cornea

 

redness

swelling

redness

swelling

1

 

 

 

 

 

 

 

 

 

 

24

1

0

0

0

48

1

0

0

0

72

0

0

0

0

average

0.67

0.0

0.0

0.0

Time to reversion

72.0

0.0

0.0

0.0

2

 

 

 

 

 

 

 

 

 

 

 

24

1

0

0

0

48

0

0

0

0

72

0

0

0

0

average

0.33

0.0

0.0

0.0

Time to reversion

48.0

0.0

0.0

0.0

3

 

 

 

 

 

 

 

 

 

 

 

24

0

0

0

0

48

0

0

0

0

72

0

0

0

0

average

0.0

0.0

0.0

0.0

Time to reversion

0.0

0.0

0.0

0.0

4

 

 

 

 

 

 

 

 

 

 

 

24

1

0

0

0

48

0

0

0

0

72

0

0

0

0

average

0.33

0.0

0.0

0.0

Time to reversion

48.0

0.0

0.0

0.0

5

 

 

 

 

 

 

 

 

 

 

 

24

1

0

0

0

48

0

0

0

0

72

0

0

0

0

average

0.33

0.0

0.0

0.0

Time to reversion

48.0

 0.0

 0.0

0.0 

6

 

 

 

 

 

 

 

 

 

 

 

24

0

0

0

0

48

0

0

0

0

72

0

0

0

0

average

0.0

0.0

0.0

0.0

Time to reversion

0.0

0.0 

0.0 

0.0 

 

 

 

Time [h]

conjunctivae

 

iris

cornea

 

redness

swelling

 

 

avg. time to reversion

36.0

0.0

0.0

0.0

average

score

 

 

 

 

 

 

24

0.67

0.00

0.00

0.00

48

0.17

0.00

0.00

0.00

72

0.00

0.00

0.00

0.00

24+48+72

0.28

0.00

0.00

0.00

 

Interpretation of results:
GHS criteria not met
Conclusions:
not irritating to the eyes
Executive summary:

An in vivo eye irritation study in rabbits was perfromed with tetradecyl myristate (CAS No. 3234 -85 -3), a constituent of the registration substance. Mean scores for cornea, iris, conjunctiva redness and chemosis for all 6 animals after 24, 48, and 72 hours were 0, 0 and in the range of 0.33 to 0.66. All effects were fully reversible within 72 h. Thus, the substance does not have to be classified according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).

Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
23 - 26 Feb 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Please refer to cread across justification justification setcion 13.2

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
Please refer to cread across justification justification setcion 13.2

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Please refer to cread across justification justification setcion 13.2

3. ANALOGUE APPROACH JUSTIFICATION
Please refer to cread across justification justification setcion 13.2

4. DATA MATRIX
Please refer to cread across justification justification setcion 13.2
Reason / purpose for cross-reference:
read-across source
Number of animals or in vitro replicates:
3
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: reversibility 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: reversibility 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: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility not applicable
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritant / corrosive response data:
At the 1-hour reading time point 3/3 rabbits had slight conjunctivae (score 1, 1, 1), which was still present in 1/3 rabbits at the 24-hour reading time point. The effect had cleared completely within 48 hours. No other eye irritation effects were observed in any rabbit at any time point (see Table 1).
Other effects:
There was no mortality, and no clinical signs were observed during the study period.

Table 1: Eye irritation scores

Rabbit #

 

Time [h]

 

conjunctivae

 

iris

 

cornea

 

redness

swelling

1

 

 

 

 

1

1 (AB)

0

0

0

24

1 (A)

0

0

0

48

0

0

0

0

72

0

0

0

0

average

0.33

0.0

0.0

0.0

2

 

 

 

 

1

1 (ABC)

0

0

0

24

0

0

0

0

48

0

0

0

0

72

0

0

0

0

average

0.00

0.0

0.0

0.0

3

 

 

 

 

1

1 (AB)

0

0

0

24

0

0

0

0

48

0

0

0

0

72

0

0

0

0

average

0.00

0.0

0.0

0.0

 

 

Time [h]

conjunctivae

 

iris

cornea

 

redness

swelling

 

 

average

score

1

1.00

0.00

0.00

0.00

24

0.33

0.00

0.00

0.00

48

0.00

0.00

0.00

0.00

72

0.00

0.00

0.00

0.00

24+48+72

0.11

0.00

0.00

0.00

A = eyelids

B = nictating membrane

C = sclera

Interpretation of results:
GHS criteria not met
Conclusions:
With reference the reported scores and the reversibility the test item does not have to be classified as irritant to the eyes according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
Executive summary:

2-octyldodecyl isooctadecanoate (CAS No 93803 -87 -3), a strucutral analogue of the registration substance, was tested for its eye irritant properties in 3 Albino-Himalayan rabbits. The study was performed according to OECD Guideline 405.

Effects on conjunctivae were observed in only one animal after application. These signs were fully reversible within 48 hours..

With reference the reported scores and the reversibility the test item does not have to be classified as irritant to the eyes according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).

Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
19 Dec - 21 Dec 1995
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Please refer to cread across justification justification setcion 13.2

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
Please refer to cread across justification justification setcion 13.2

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Please refer to cread across justification justification setcion 13.2

3. ANALOGUE APPROACH JUSTIFICATION
Please refer to cread across justification justification setcion 13.2

4. DATA MATRIX
Please refer to cread across justification justification setcion 13.2
Reason / purpose for cross-reference:
read-across source
GLP compliance:
not specified
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: reversibility 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: reversibility not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: no details reported

Table 1: Results of eye irritation test

Rabbit No. / sex

Scoring [h]

Cornea

Iris

Conjunctiva

1 / m

1

0

0

1

 

24

0

0

1

 

48

0

0

0

 

72

0

0

0

 

7 days

0

0

0

Mean (24, 48, 72 h)

0

0

0.33

2 / m

1

0

0

2

 

24

0

0

1

 

48

0

0

0

 

72

0

0

0

 

7 days

0

0

0

Mean (24, 48, 72 h)

0

0

0.33

3 / m

1

0

0

2

 

24

0

0

1

 

48

0

0

0

 

72

0

0

0

 

7 days

0

0

0

Mean (24, 48, 72 h)

0

0

0.33

Interpretation of results:
GHS criteria not met
Conclusions:
With reference the reported scores and reversibility of effects within 48 hours the test itemdoes not have to be classified as irritant to the eyes according to the criteria laid down in the EU Classification & Labelling and Packaging Regulation (1272/2008/EC).
Executive summary:

2 -Ethylhexyl laurate, a structural analogue of the registration substance, was tested for its eye irritant properties in 3 New Zealand White rabbits. The study was performed according to OECD Guideline 405.

Effects on conjunctivae were observed in one animal after application. These signs were fully reversible within 48 hours.

With reference the reported scores and reversibility of effects within 48 hours the test itemdoes not have to be classified as irritant to the eyes according to the criteria laid down in the EU Classification & Labelling and Packaging Regulation (1272/2008/EC).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

With reference the reported scores and the full reversibility of effects it is concluded that the registration substance does not have to be classified neither as irritant to the skin nor as eye irritating according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).