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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:
1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Test material form:
liquid: viscous
Details on test material:
- Manufacturers identification: Novares LA 300
- Substance type: organic
- Test material is 'Oligomerisation and alkylation reaction products of 2-phenylpropene and phenol' (OAPP), EC list number 700-960-7 (assigned manually to validated substances from inquiries by ECHA). Originally the substance phenol, methylstyrenated, CAS No. 68512-30-1, EC No. 270-966-8 was submitted for registration. Subsequent to substance validation, the identity of the substance was changed by ECHA.
- for additional information see respective study record
Specific details on test material used for the study:
- Name of test material (as cited in study report): Necires EPX-L (phenol, methylstyrenated)
- Impurities (identity and concentrations): None
- Purity test date: Unknown
- Lot/batch No.: 9356059
- Expiration date of the lot/batch: 2005/02/01
- Stability under test conditions: Stable
- Storage condition of test material: At room temperature in the dark

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: 14 - 15 weeks
- Weight at study initiation: 2683 -2763 grams
- Housing: Individually in labelled cages with perforated floors and equipped with an automatic drinking system (ITl, Bergen, The Netherlands).
- Diet (e.g. ad libitum): Standard laboratory rabbit diet (LKK-20, pellet diameter 4mm, Hope Farms, Woerden, The Netherlands) approx. 100 gram per day. In addition, hay (BMI, Helmond, the Netherlands) was provided once a week. Certificates of analysis were examined and retained in the NOTOX archives.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: Acclimatisation period was at least 5 days before start of treatment under laboratory conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours light

IN-LIFE DATES: From: To:

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): 100 %
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
1, 24, 48 and 72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure: 24 hours

SCORING SYSTEM: OECD 405, Draize et a1. 1944. J. Pharmacal. Exp. Ther. 82; 377-390 and J. Soc. Cosmet. Chem. 13; 281-289

TOOL USED TO ASSESS SCORE: fluorescein

CONTROL
The eye not being treated served as a control

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
Instillation of 0.1 ml of NECIRES EPX-L into one eye of each of the animals resulted in minimal irritation of the conjunctivae. The irritation consisted of chemosis in two animals (nos. 1941 and 1975) and redness in all three animals, which had completely resolved within 48 hours after instillation. A small amount of discharge was also observed in one animal (no. 1941) 1 hour after instillation. Treatment of the eyes with 2% fluorescein, 24 hours after test substance instillation revealed no corneal epithelial damage in any of the animals.
Other effects:
There was no evidence of ocular corrosion nor was there any peri-ocular staining of tissues by the test substance.
No toxic symptoms were observed in the animals during the test period and nomortality occurred.

Any other information on results incl. tables

INDIVIDUAL OCULAR CHANGES

Time after dosing

Tissue/Finding

Animal 1935 (#1)

Animal 1941 (#2)

Animal 1975 (#3)

1 hour

Corneal opacity

             area

0

0

0

0

0

0

Iris

0

0

0

Conj.: redness

          chemosis

1(A,B,C)

0

1(A,B,C)

1(A)

1(A,B,C)

1(A)

Discharge

0

1

0

24 hours

Corneal opacity

             area

0

0

0

0

0

0

Iris

0

0

0

Conj.: redness

          chemosis

0

0

1(A,C)

0

0

0

Discharge

0

0

0

48 hours

Corneal opacity

             area

0

0

0

0

0

0

Iris

0

0

0

Conj.: redness

          chemosis

0

0

0

0

0

0

Discharge

0

0

0

72 hours

Corneal opacity

             area

0

0

0

0

0

0

Iris

0

0

0

Conj.: redness

          chemosis

0

0

0

0

0

0

Discharge

0

0

0

 

(.) = Score given for: A = Eyelids

                                B = Nictitating membrane

                                C = Sclera      

DRAIZE SCORE CALCULATIONS

Animal no.

Tissue

Hours after application

1 hour

24 hours

48 hours

72 hours

1935 (#1)

Cornea

0

0

0

0

Iris

0

0

0

0

Conjunctivae

2

0

0

0

Subtotal

2

0

0

0

1941 (#2)

Cornea

0

0

0

0

Iris

0

0

0

0

Conjunctivae

6

2

0

0

Subtotal

6

2

0

0

1975 (#3)

Cornea

0

0

0

0

Iris

0

0

0

0

Conjunctivae

4

0

0

0

Subtotal

4

0

0

0

 

Total

12

2

0

0

 

Mean total

4

0.7

0

0

                                   

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Necires EPX-L (phenol, methylstyrenated) is not irritating to eyes acccording to EU/GHS classification criteria as demonstrated in a test according to OECD TG 405.
Executive summary:

Three male rabbits had 0.1 ml phenol, methylstyrenated instilled in their eyes for 24 hours. Following this period, the test substance was washed out, using 2 % fluorescein in water to reveal any signs of irritation. The instillation resulted in minimal irritation of the conjunctivae, irritation of chemosis in two animals and redness in all three animals. In one animal a small amount of dicharge was observed 1 hour after instillation. These symptoms were resolved 48 hours after instillation, and no corneal epithelial damage was seen in any of the animals 24 hours after the instillation. There was no evidence of ocular corrosion nor was there any peri-ocular staining of tissues by the test substance. No toxic symptoms were observed in the animals during the test period, and no mortality occurred. In conclusion, instillation of the test substance into rabbit eyes induced minimal irritation, which was reversible within 48 hours.