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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
From 28 February 2000 to 27 October 2003
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study is a screening test but followed international guidance requirements with acceptable restrictions.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
: screening study, only one tested animal, no certificate of analysis included
Principles of method if other than guideline:
Not applicable
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: Liquid at ambient temperature
Details on test material:
- Name of test material (as cited in study report): Dermalcare MAP L-213/K
- Physical state: clear liquid
- Stability under test conditions: assumed to be stable by the sponsor
- Storage condition of test material: ambient temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River Italia S.p.A
- Age at study initiation: no data
- Weight at study initiation: 2.8 kg
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: From: To: no data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the left eye remained untreated
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): not applicable

VEHICLE
not applicable
Duration of treatment / exposure:
the eye was not rinsed after administration of test item
Observation period (in vivo):
Ocular reactions were observed approximately 1 hour, 24, 48 and 72 hours after the instillation and then at days 7, 14 and 21.
Number of animals or in vitro replicates:
1
Details on study design:
REMOVAL OF TEST SUBSTANCE
not applicable

SCORING SYSTEM: Draize scale

TOOL USED TO ASSESS SCORE: no data

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 21 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Irritant / corrosive response data:
Corneal opacity was observed at 24 and 48 hours (grade 1) and persisted with grade 2 from 72 hours until the end of the study period (day 21). Iris inflammation (grade 1) was observed from the 24-hour observation until the end of the study. The mean scores calculated over the 24-48-72 hours period were 1.33 for corneal opacity, and 1.0 for iris inflammation.
Conjunctival reactions, redness (grade 2) and chemosis (grade 2 or 3) were observed between 1 and 72 hours, and then cleared by day 21. The mean scores (24-48-72 hours) were 2.0 for conjunctival redness, and 3.0 for chemosis. In addition, discharge was observed between 1 and 72 hours following administration (see details in Table 7.3.2/1).
Other effects:
none

Any other information on results incl. tables

Table 7.3.2/1: Irritant/corrosive response data at each observation time up to removal of animal from the test (21 days)

Score at time point / Reversibility

Cornea

Iris

Conjunctivae

Chemosis

Max. score: 4

Max. score: 2

Max. score: 3

Max. score: 4

60 min

0

0

2

2

24 h

1

1

2

3

48 h

1

1

2

3

72 h

2

1

2

3

7 days

2

1

1

1

14 days

2

1

1

1

21 days

2

1

0

0

Average 24h, 48h, 72h

1.3

1.0

2.0

3.0

Reversibility*)

n

n

c

c

Average time (day) for reversion

-

-

21

21

*) Reversibility: c. = completely reversible;n.c.= not completely reversible; n. = not reversible

OP: Scoring masked by marked corneal opacity

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:
Under the test conditions, Dermalcare MAP L-213/K induced irreversible eye damage (persistent corneal and iridal effects on day 21) and is therefore classified as Eye Dam. 1 (H318) according to the criteria of the Regulation (EC) 1272/2008 (CLP) or to the criteria of the Directive 67/548/EEC.
Executive summary:

In an eye irritation screening study performed similarly to the OECD No. 405 guideline, 0.1 mL of undiluted Dermalcare MAP L-213/K was instilled into the conjunctival sac of right eye of one male New Zealand White Rabbit. After the instillation the substance was not rinsed off. The animal was then observed for 21 days for eye edema and erythema of the conjunctivae, corneal opacity and iris lesion. Eye irritation was assessed and scored according to the Draize scale at 1,24, 48 and 72 hrs, 7, 14 and 21 days after the instillation of the substance. The mean individual scores were calculated within 3 scoring times (24, 48 and 72 hrs).

The mean score was 1.3 for corneal opacity, 1.0 for the iris lesion, 3.0 for chemosis and 2.0 for conjunctival erythema. While the effects on the conjunctivae (redness and chemosis) were fully reversible within 21 days, effects on the cornea and on the iris were irreversible over the 21 -day observation period.

 

Therefore, under the test conditions, Dermalcare MAP L-213/K induced irreversible damage to the rabbit eye and is classified as Eye Dam. 1 (H318) according to the criteria of the Regulation (EC) 1272/2008 (CLP) and as Xi, R41according to the criteria of the Directive 67/548/EEC.