N-(n-dodecyl)pyrrolidinone

Eye irritation

Administrative data

Endpoint:

eye irritation, other

Remarks:

Data available from in-vivo studies preformed before the in-vitro requirement.

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

From 12 to 23 June 1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study run to a method comparable with current guidelines

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: modification of that described by J.H. Draize.

Deviations:

no

GLP compliance:

no

Test material

Reference

Name:

Unnamed

Type:

Constituent

Type:

Constituent

Details on test material:

Identification Number: 9083-5,5-9-86
Purity: not specified

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: a suitable licensed dealer
- Age at study initiation: 3 months
- Weight at study initiation: approximately 2 kilograms
- Housing: housed in galvanized or stainless steel cages, in a temperature controlled room
- Diet (e.g. ad libitum): consisted of a growth and maintenance ration from a commercial producer. ad libitum
- Water (e.g. ad libitum): consisted of a growth and maintenance ration from a commercial producer. ad libitum
- Acclimation period: at least 3 days

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.1ml

Duration of treatment / exposure:

the first six rabbits 24 hours, the remaining three 30 seconds

Observation period (in vivo):

21 days

Number of animals or in vitro replicates:

9

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done):with sufficient lukewarm water at room temperature
- Time after start of exposure:The eyes of the first six animals remained unwashed for 24 hours. The eyes of the remaining three rabbits were irrigated 30 seconds following instillation of the test article.

SCORING SYSTEM:Draize scale

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: Mean of 24, 48 & 72 hrs

Score:

ca. 1.56

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: After 21 days all animals has a score of 4

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: Mean of 24, 48 & 72 hrs

Score:

ca. 0.83

Max. score:

1

Reversibility:

not reversible

Remarks on result:

other: The score of 1 persisited after 21 days in 5 of 6 animals.

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: Mean of 24, 48 & 72 hrs

Score:

ca. 2.11

Max. score:

2

Reversibility:

not fully reversible within: 21 days

Remarks on result:

other: The score of 1 persisted after 21 days in 5 of 6 animals.

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: Mean of 24, 48 & 72 hrs

Score:

ca. 3.17

Max. score:

4

Reversibility:

not fully reversible within: 21

Remarks on result:

other: Signs persisted after 21 days in 5 of 6 animals

Irritant / corrosive response data:

The results presented above relate to the 6 animals treated for 24 hours and exclude those exposure only for 30 seconds. Severe corneal opacity, iritis and conjunctivitis were observed.

Other effects:

Blanching, bloody discharge, fibrovascular connective tissue and nodular mass subjacent to meibomian gland were also evident throughout the observation period.

Any other information on results incl. tables

0.1mL, neat

Draize  Scores
Group	Hours			Days
	24	48	72	4	7	14	21
Unwashed	37.7	36.3	37.2	38.3	60.7	83.3	72.2
30” Wash	32.3	31.0	32.3	30.7	32.7	18.0	13.3

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

This test substance is a severe ocular irritant to rabbits under conditions of this test. The wash procedure reduced the severity of the irritation observed.