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Diss Factsheets

Administrative data

Description of key information

Based on the study results, it is concluded that the substance was not irritating to the skin of the rabbits.
The results indicated that the substance was not irritating to the eyes of rabbits.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Study period:
1988-08-01 to 1988-08-05
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Cited from ECHA disseminated dossier Query date: 2015-07-22 For justification of read across please refer to IUCLID section 13.
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
4 hours
Observation period:
7 days
Number of animals:
1 male and 2 females
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48, 72 hrs
Score:
>= 1 - <= 2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Average score: 1.3
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 48, 72 hrs
Score:
0
Max. score:
4
Remarks on result:
other: Average score: 0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48, 72 hrs
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Average score: 1
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 48, 72 hrs
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Average score: 0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48, 72 hrs
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Average score: 1
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24, 48, 72 hrs
Score:
>= 0 - <= 1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Average score: 0.3

Skin irritation scores:

Time period

Animal

Sex

Erythema

Edema

Cumulative Score

Mean Cumulative Score

1HR

4

M

1

0

1

1.33

5

F

1

0

1

6

F

1

1

2

24HRS

4

M

1

0

1

1.33

5

F

1

0

1

6

F

1

1

2

48HRS

4

M

1

0

1

1

5

F

1

0

1

6

F

1

0

1

72HRS

4

M

2

0

2

1.33

5

F

1

0

1

6

F

1

0

1

7 DAYS

4

M

0

0

0

0

5

F

0

0

0

6

F

0

0

0

Skin irritation: mean scores

Animal

Sex

Erythema

Edema

Cumulative Score

Mean Cumulative Score

4

M

1.33

0

1.33

1.22

5

F

1

0

1

6

F

1

0.33

1.33

Selected observations for mean scores: 24h, 48h and 72h.

Irritation

Alkyl (C13-C15)-glycidylether showed a primary irritation score of 1.22 when applied undiluted to intact rabbit skin.

Local signs (mean 1 hour to 7 days) consisted if grade 0.87 erythema and grade 0.13 edema.

Coloration

In the area of application no staining of the treated skin by pigment or coloring of the test article was observed.

Body weights

The body weight gain of all rabbits was similar.

Toxic symptoms / mortality

No acute toxic symptoms were observed in the animals during the test period, and no mortality occurred.

Necropsy

No necropsy was performed at termination of observation.

 

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:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Study period:
From 1988-08-04 to 1988-08-11
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Cited from ECHA disseminated dossier Query date: 2015-07-22 For justification of read across please refer to IUCLID section 13.
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
no data
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
2 males and 1 female
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 hrs
Score:
0
Max. score:
4
Remarks on result:
other: Average score: 0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 hrs
Score:
0
Max. score:
2
Remarks on result:
other: Average score. 0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 hrs
Score:
0
Max. score:
3
Remarks on result:
other: Average score: 0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 hrs
Score:
0
Max. score:
4
Remarks on result:
other: Average score: 0
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 48, 72 hrs
Score:
0
Max. score:
13
Remarks on result:
other: Average score: 0

Eye irritation scores:

Time

Animal

Sex

Cornea opacity

Iris

Conjunctivae

Cumul.Score

Mean Cumul. Score

Redn.

Chem.

1HR

27

M

0

0

1

0

1

1.33

28

M

0

0

1

1

2

29

F

0

0

1

0

1

24HRS

27

M

0

0

0

0

0

0

28

M

0

0

0

0

0

29

F

0

0

0

0

0

48HRS

27

M

0

0

0

0

0

0

28

M

0

0

0

0

0

29

F

0

0

0

0

0

72HRS

27

M

0

0

0

0

0

0

28

M

0

0

0

0

0

29

F

0

0

0

0

0

Results:

Toxic symptoms / Mortality

No acute toxic symptoms were observed in the animals during the test period, and no mortality occurred.

Irritation

Alkyl (C13-C15) glycidylether showed a primary irritation score of 0.33, when applied undiluted to the rabbit eye mucosa.

Coloration

No corrosion of the cornea was observed at any of the measuring intervals.

Body weights

The body weight gain of all rabbits was similar.

Necropsy

No necropsy was performed. All animals were killed and discarded.

 

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation / corrosion

This study was conducted according to OECD guideline and EU method in order to evaluate the irritation potential of Alkyl (C13-C15) – glycidylether to the skin. 1 male and 2 female rabbits were used in the study. 0.5 ml of the substance was applied to the intact skin of the shaved areas of the each rabbit for 4 hours and the untreated skin areas of the rabbit serve as the control. All rabbits were examined for signs of erythema and oedema at 24, 48 and 72 hours after patch removal.

The results showed that the substance caused slight erythema during the examination period, however the reversibility of this reaction was observed at day 7 after the substance treatment. In addition the score for erythema and oedema formation can not meet the criteria of any category for skin corrosion/irritation under CLP.

Based on the study results, it is concluded that the substance was not irritating to the skin of the rabbits.

Eye irritation

This study was conducted according to OECD guideline and EU method in order to evaluate the risk potential of Alkyl (C13-C15) – glycidylether to the eyes. 2 male and 1 female rabbits were used in the study. 0.1 ml of the substance was placed in the conjunctiva sac of the left eye of each rabbit and the right eye served as control. Then the eyes were washed after 24 hours. The examination results showed that only slight erythema was observed in the three rabbits after 1h and no abnormalities were observed after 24h, 48h and 72h. The results indicated that the substance was not irritating to the eyes of rabbits.


Justification for selection of skin irritation / corrosion endpoint:
The results showed that the substance caused slight erythema during the examination period, however the reversibility of this reaction was observed at day 7 after the substance treatment. In addition the score for erythema and oedema formation can not meet the criteria of any category for skin corrosion/irritation under CLP.
Based on the study results, it is concluded that the substance was not irritating to the skin of the rabbits.

Justification for selection of eye irritation endpoint:
The examination results showed that only slight erythema was observed in the three rabbits after 1h and no abnormalities were observed after 24h, 48h and 72h. The results indicated that the substance was not irritating to the eyes of rabbits.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified as irritating for skin or eyes under Directive 67/548/EEC.

                                             

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for irritation under Regulation (EC) No. 1272/2008.