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Toxicological information

Eye irritation

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Administrative data

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:
comparable to guideline study

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986
Reference Type:
publication
Title:
Five Toxicity Screening Studies with 2-Ethylhexanoyl chloride
Author:
PPG Ind. Inc., USA
Year:
1987
Bibliographic source:
TSCATS, OTS 0513463, Doc. I.D. 89-878000001
Reference Type:
secondary source
Title:
SIDS Initial Assessment Report for SIAM 27 - Acid Chlorides (AC) Category
Author:
OECD SIDS
Year:
2008
Bibliographic source:
OECD SIDS

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-ethylhexanoyl chloride
EC Number:
212-081-1
EC Name:
2-ethylhexanoyl chloride
Cas Number:
760-67-8
Molecular formula:
C8H15ClO
IUPAC Name:
2-ethylhexanoyl chloride
Details on test material:
Purity of test material was not analytically confirmed. It was used as received from PPG Industries. Purity of that material is listed as > 98% on the MSDS

Test animals / tissue source

Species:
rabbit
Strain:
not specified

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The untreated left eye served as a control.
Amount / concentration applied:
100 µL
Duration of treatment / exposure:
In 3/9 animals the treated eyes were washed out after 30 sec; in all other animals, washing was not performed
Observation period (in vivo):
21 d
Number of animals or in vitro replicates:
9
Details on study design:
A test with fluorescein showed that the eyes were normal prior to testing. Test material (0.1 ml) was placed into the conjunctival sac of the right eye of each of 9 animals. The lids were held together for one second. Three of the nine treated eyes were each washed with room temperature deionized water for 1 minute, 30 seconds after treatment.
The treated eyes were examined for irritation 1, 24, 48 hours and 4, 7, 10, 14, 17 and 21 days after treatment. The corneas were re-examined after treatment with 0.2% fluorescein sodium ophthalmic solution after the 24 hour observation time. If staining was observed, staining was repeated after each subsequent evaluation time until staining no longer occurred.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
unwashed eyes
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Remarks:
unwashed eyes
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
unwashed eyes
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Remarks:
unwashed eyes
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Remarks:
unwashed eyes
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #4
Remarks:
unwashed eyes
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritation parameter:
conjunctivae score
Basis:
animal #5
Remarks:
unwashed eyes
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritation parameter:
conjunctivae score
Basis:
animal #6
Remarks:
unwashed eyes
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
unwashed eyes
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
unwashed eyes
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
unwashed eyes
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #4
Remarks:
unwashed eyes
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #5
Remarks:
unwashed eyes
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #6
Remarks:
unwashed eyes
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritant / corrosive response data:
Positive staining occurred in four nonwashed eyes, which resolved by 48 hours. Positive staining did not occur in any of the washed eyes.
Since corneal involvement and/or conjunctival irritation cleared in 7 days or less, the test material was categorized as Toxicity Category III.

Any other information on results incl. tables

Readings

(nonwash)

Animal (male)

Cornea

Iris

Conjunctiva

op

ar

red

Sw

1 h

1

0

0

0

3

2

2

+

3

0

2

3

3

1

2

0

 3

3

24 h

1

+

1

0

2

1

2

0

0

0

2

1

3

0

0

0

1

0

48 h

1

0

0

0

1

0

2

0

0

0

1

1

3

0

0

0

0

0

72 h

1

0

0

0

1

0

2

0

0

0

 1x

 0

3

0

0

0

0

0

4 days

1

0

0

0

1

0

2

0

0

0

1

0

3

0

0

0

0

0

7 days

1

0

0

0

0

0

2

0

0

0

 0y

 0

3

0

0

0

 0x

0

Mean  (24-48-72 h)

1

0

0.3

0

1.3

0.3

2

0

0

0

1.3

0.67

3

0

0

0

0.3

0

 

 

 

 

 

 

 

Readings

(nonwash)

Animal

(male)

Cornea

Iris

Conjunctiva

op

ar

red

sw

1 h

4

+

1

0

2

3

5

2

2

1c

2

2

6

+

2

0

2

3

24 h

4

+

1

0

2

1

5

+

2

0

2

0

6

+

1

0

1

0

48 h

4

0

0

0

1

0

5

0

0

0

1

0

6

0

0

0

1

0

72 h

4

0

0

0

0

0

5

0

0

0

  1

0

6

0

0

0

 1x

0

4 days

4

0

0

0

0

0

5

0

0

0

0

0

6

0

0

0

0

0

7 days

4

0

0

0

 0x

0

5

0

0

0

 0x

0

6

0

0

0

0

0

Mean  (24-48-72 h)

4

0

0.33

0

1

0.3

5

0

0.67

0

1.3

0

6

0

0.33

0

1

0

a - Animal exhibited apparent pain (squealing) at time of treatment.

+ slight dulling of normal luster

c - Constricted pupil.

x - Slight hair loss adjacent to eyelid.

y - Moderate hair loss adjacent to eyelid.

Readings

(wash)

Animal (female)

Cornea

Iris

Conjunctiva

op

ar

red

Sw

1 h

7

0

0

0

2

2

8

0

0

0

2

2

9

0

0

0

2

2

24 h

7

0

0

0

1

0

8

0

0

0

1

1

9

0

0

0

1

0

48 h

7

0

0

0

1

0

8

0

0

0

1

1

9

0

0

0

1

0

72 h

7

0

0

0

1x

1

8

0

0

0

0

0

9

0

0

0

1

0

4 days

7

0

0

0

1

0

8

0

0

0

0

0

9

0

0

0

1

0

7 days

7

0

0

0

0

0

8

0

0

0

0

0

9

0

0

0

0

0

Mean  (24-48-72 h)

7

0

0

0

1

0.3

8

0

0

0

0.67

0.67

9

0

0

0

1

0

 

 

 

 

 

 

 

x - Slight hair loss adjacent to eyelid.

Applicant's summary and conclusion

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