Registration Dossier

Administrative data

Description of key information

Dermal irritation -  Not irritating 
Eye irritation - Not irritating
Primary dermal irritation index (4.5, 24, 48 and 72 h score average) was 0.
Not irritating Category III for eye effects – corneal involvement or irritation clearing in 7 days or less.

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Valid without restriction. Well documented GLP study.
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
EPA Guideline 81-5
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Duration of treatment / exposure:
4 hours
Observation period:
The skin was examined at 0.5, 24, 48, and 72 hours after removal of the patches.
Number of animals:
6
Irritation parameter:
primary dermal irritation index (PDII)
Time point:
other: 4.5, 24, 48 and 72 h score average
Score:
0

Rabbit No.

 

0.5

hrs

24

hrs

48 hrs

72

hrs

599

Erythema-Eschar

Edema

0

0

0    

0

0

0

0

0

600

Erythema-Eschar

Edema

0

0

0    

0

0

0

0

0

601

Erythema-Eschar

Edema

0

0

0    

0

0

0

0

0

602

Erythema-Eschar

Edema

0

0

0    

0

0

0

0

0

603

Erythema-Eschar

Edema

0

0

0    

0

0

0

0

0

604

Erythema-Eschar

Edema

0

0

0    

0

0

0

0

0

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Primary dermal irritation index (4.5, 24, 48 and 72 h score average) was 0. Not irritating.
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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Valid without restriction. Well documented GLP study.
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
EPA Guideline 81-4
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
other: The other eye was left untreated as a negative control.
Duration of treatment / exposure:
7 days
Observation period (in vivo):
1, 24, 48, 72, and 168 hrs.
Number of animals or in vitro replicates:
6
Irritation parameter:
overall irritation score
Time point:
other: 6
Other effects:
No lesions observed
One hour after application, all six animals animal were positive for conjunctival symptoms and two animals showed iris effects. Maximum irritation effects
were seen at 24 hrs (group mean score 22.5/110) when corneal opacity was also observed in five animals.
After 168 hours, only one animal showed irritation effects. The scores for each animal at each reading, and the mean score for each animal are shown in the
tables below.

Group Mean Scores for Ocular Lesions (Draize values)

Rabbit No.

 

1 hr.

24 hrs.

48 hrs.

72 hrs.

168 hrs. (7 days)

611

Cornea opacity, degree

Cornea opacity, area

Iris

Conjunctiva

     Redness

     Chemosis

     Discharge

    

 

--

--

0

 

2

2

2

 

1

2

1

 

2

2

3

 

0

0

0

 

2

1

1

 

0

0

0

 

2

1

1

 

0

0

0

 

0

0

0

612

Cornea opacity, degree

Cornea opacity, area

Iris

Conjunctiva

     Redness

     Chemosis

     Discharge

 

 

--

--

0

 

2

2

2

 

1

1

0

 

2

2

3

 

0

0

0

 

2

1

1

 

0

0

0

 

1

1

1

 

0

0

0

 

0

0

0

613

Cornea opacity, degree

Cornea opacity, area

Iris

Conjunctiva

     Redness

     Chemosis

     Discharge

    

 

--

--

1

 

2

2

2

 

1

3

1

 

2

2

3

 

1

1

0

 

2

1

1

 

0

0

0

 

1

1

1

 

0

0

0

 

0

0

0

614

Cornea opacity, degree

Cornea opacity, area

Iris

Conjunctiva

     Redness

     Chemosis

     Discharge

    

 

--

--

0

 

2

1

1

 

1

1

0

 

2

1

2

 

0

0

0

 

1

0

0

 

0

0

0

 

1

0

0

 

0

0

0

 

0

0

0

615

Cornea opacity, degree

Cornea opacity, area

Iris

Conjunctiva

     Redness

     Chemosis

     Discharge

    

 

--

--

0

 

1

1

1

 

0

0

0

 

2

1

1

 

0

0

0

 

1

0

0

 

0

0

0

 

1

0

0

 

0

0

0

 

0

0

0

616

Cornea opacity, degree

Cornea opacity, area

Iris

Conjunctiva

     Redness

     Chemosis

     Discharge

    

 

--

--

1

 

2

2

2

 

1

3

1

 

2

2

3

 

1

1

0

 

2

1

1

 

0

0

0

 

2

1

1

 

0

0

0

 

0

0

0

Group Mean Scores for Ocular Lesions (Draize values)

Average

1 hr.

24 hrs.

48 hrs

72 hrs.

168 hrs

Cornea

--

8.3

1.7

0.0

0.0

Iris

1.7

2.5

0.0

0.0

0.0

Conjunctiva

10.3

11.7

5.0

4.7

0.0

Total

12.0

22.5

6.7

4.7

0.0

Interpretation of results:
Category III
Remarks:
Migrated information Criteria used for interpretation of results: other: OECD No. 405 (1987) and EPA Guideline 81-4
Conclusions:
EPA/OECD Toxicity Category III for eye effects – corneal involvement or irritation clearing in 7 days or less.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Skin:

Irritation to skin was evaluated in a study performed according to GLP and OECD guideline 404 and EPA Guideline 81-5 with a primary irritation index (4.5, 24,48 and 72 h) of 0. 

Eyes:

Irritation to eye was evaluated in a study performed according to GLP and OECD guideline 405 and EPA Guideline 81-4. Both eyes of the animals were examined one day before the application of the test material for ocular lesions.  A single application of 0.1 ml (40 - 43 mg) packed volume of finely ground test material was added to the conjunctival sac of one eye, and the eyelids were gently held together for 1 second.  The eyes were graded for ocular reaction at 1 and 24 hours.  A 2% sodium fluorescein solution was instilled after 24 hours and the eyes examined again with UV-light to evaluate potential corneal damage. The eyes were also examined at 48, 72 and 168 hours (7 days) and scored for corneal opacity, iris lesions, chemosis, and conjunctival redness. EPA/OECD Toxicity Category III for eye effects – corneal involvement or irritation clearing in 7 days or less.

Justification for classification or non-classification

According to DSD (67/548/EEC) or CLP (1272/2008/EC) classification criteria for irritation/corrosion, 1,18 octadecanedioic acid does not fulfill the criteria for classification and thus a non-classification is warranted for this endpoints.