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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
Study period:
1998-09-15 to 1998-10-13
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline conform study report, GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

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

Test material

Constituent 1
Reference substance name:
1888-91-0
IUPAC Name:
1888-91-0
Constituent 2
Chemical structure
Reference substance name:
N-acetylhexanelactam
EC Number:
217-565-6
EC Name:
N-acetylhexanelactam
Cas Number:
1888-91-1
Molecular formula:
C8H13NO2
IUPAC Name:
N-acetylhexanelactam
Test material form:
other: liquid, clear yellowish
Details on test material:
- Name of test material: Acetylcaprolactam
- Physical state: liquid
- Analytical purity: 100%
- Lot/batch No.: Op.2
- Expiration date of the lot/batch: December 1999
- Storage condition of test material: darkness at room temperature in fume cupboard

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
24 hours after administration the eyes were washed out thoroughly with isotonic saline at approx. 37°C.
Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2.33
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.33
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.67
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.67
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
other: opacity area
Basis:
animal #1
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
other: opacity area
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.33
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
other: opacity area
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0.55
Max. score:
1
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
2.78
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
1.56
Max. score:
2.33
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0.67
Max. score:
1
Irritant / corrosive response data:
One hour up to 72 hours after administration the conjunctivae of the animals showed a diffuse crimson red up to a diffuse breefly red color and very slight swellings up to swellings with lids about half closed. The iris was sporadically reddened and the cornea showed diffuse opacity areas. Additionally, serous-colorless eye discharge was noted. Seven days after administration definitely injected blood vessels of the conjunctivae were observed in all animals. 14 days after administration all signs of irritation were reversible. The eye reactions were assessed according to the numerical scoring system (acc. to Draize) at 24, 48 and 72 hours and additionally 7 and 14 days after treatment. Individual mean animal data for opacity of cornea were 1.00, 1.00 and 0.00 for animals 1, 2 and 3, respectively. Individual mean animal data for iris were 1.00, 0.33 and 0.33 for animals 1, 2 and 3, respectively. Individual mean animal data for redness of conjunctiva were 3.00, 3.00 and 2.33 for animals 1, 2 and 3, respectively. Individual mean animal data for chemosis of conjunctiva were 2.33, 1.67 and 0.67 for animals 1, 2 and 3, respectively.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
N- Acetylhexanelactam causes serious eye irritation.
Executive summary:

In order to assess the eye irritating potential of the test substance, 0.1 mL of the undiluted test item was applied into the conjunctival sac of the left eye. The untreated eye serves as control. 24 hours after treatment and at any time point when the cornea needs to be inspected with fluorescein-sodium solution, the eye was washed with physiological saline solution (Temperature about 37°C). The assessment was performed 60 minutes, 24, 48 and 72 hours after application of test item and additionally after 7 and14 days due to some findings. The eye reactions were assessed according to the numerical scoring system (acc. to Draize). The description of the degree and nature of irritation, the presence of serious lesions and non-occular effects were noted. Mean values obtained from all three tested eyes were for cornea opacity 0.67, iris 0.55, redness of conjunctiva 2.78 and chemosis of conjunctiva 1.56. 14 days after administration all signs of irritation were reversible. Based on the findings of this OECD 405 study in New Zealand White rabbits, the test substance is determined to be eye irritant.