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Administrative data

Description of key information

The primary dermal irritation capacity of Acetylcaprolactam was tested in an OECD 404 guideline study. The test substance was found to be not irritant to the skin.
The primary eye irritating capacity of Acetylcaprolactam was tested in an OECD 405 guideline study. The test substance was found to be irritating to eyes.

No study on respiratory irritation is available.

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
Study period:
1998-09-08 to 1998-09-11
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline conform study report, GLP.
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Remarks:
Statement
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
0.22
Max. score:
0.33
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect observed
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect obseved
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect observed
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect observed
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect observed
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of this OECD 404 study the test substance was determined to be not irritant to the skin.
Executive summary:

The primary dermal irritation of the test substance to the New Zealnd White rabbits was tested in an OECD 404 study. The test substance was administered on a 2.5 x 2.5 cm cellulose patch on a piece of surgical plaster and then fixed on the clipped dorsal region of the body. Each animal was treated with 0.5 mL of the test substance. The fixed plaster was then covered with a semi-occlusive bandage for 4 hours. After the exposure period all remnants of the test substance were carefully removed from the skin with warm tap water. Examinations of the skin took place after 30 -60 minutes as well as 24, 48 and 72 hours after removal of the patches. After 30 -60 minutes and 24 hours after removal of the plaster the animals showed sporadically very slight erythema. At 48 hours after removal of the plaster all signs of irrtation were reversible. Based on the results of this study the test substance was determined to be not irritant to the skin.

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
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
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Remarks:
statement
Species:
rabbit
Strain:
New Zealand White
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
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.
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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Based on the findings of an OECD 404 study in New Zealand White rabbits, Acetylcaprolactam is not irritating to the skin.

Based on the findings of an OECD 405 study in New Zealand White rabbits, Acetylcaprolactam is irritating to eyes.

No study on respiratory irritation is available.


Justification for classification or non-classification

Based on the findings of an OECD 404 study in New Zealand White rabbits, Acetylcaprolactam is not irritating to the skin. No classification is indicated.

Based on the findings of an OECD 405 study in New Zealand White rabbits, Acetylcaprolactam irritating to eyes. According to the Regulation (EC) No 1272/2008 of the European Parliament and of the Council, 16 December 2008 (CLP or GHS (Global Harmonized System for classification, labeling and packaging) Annex 1, Chapter 3.3.2.7.1 the test substance has to be classified: Cat 2, causes serious eye irritation.