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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:
no data available
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study is sufficiently documented. OECD guideline Study; analytical purity of test substance: 70%

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
sodium diisobutylnaphtalene sulfonate
Cas Number:
91078-64-7
IUPAC Name:
sodium diisobutylnaphtalene sulfonate
Test material form:
other: solid
Details on test material:
See confidential details on test material section

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach/Main, Germany
- Weight at study initiation: female: 2.94 kg and male (mean): 3.09 kg
- Housing: single
- Diet: about 130 g per animal per day
- Water: about 250 mL per animal per day
- Acclimation period: at least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: yes, untreated eye of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL bulk volume (about 36 mg of the comminuted test substance)
Duration of treatment / exposure:
single application (test substance was not washed out)
Observation period (in vivo):
21 days
readings: 1, 24, 48, 72 hours and 8, 15, 21 days after application
Number of animals or in vitro replicates:
2 males and 1 female
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: as described in OECD 405

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48, 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24, 48, 72 hours
Score:
1
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24, 48, 72 hours
Score:
1
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48, 72 hours
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal 1 -3
Time point:
other: 24, 48, 72 hours
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks:
except animal #1 where the effects were fully reversible within 8 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48, 72 hours
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48, 72 hours
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 21 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24 hours
Irritant / corrosive response data:
Result: The substance was severely irritating to the eye in the rabbit. Persistence of eye damages at the end of the observation period (21 days)

See details in table below

Any other information on results incl. tables

Detailed results:

Readings

animal

cornea opacity

iris

redness

chemosis

symptoms

1 hour

 

 

1

1

0

2

1

RE

2

1

0

2

1

3

1

0

2

1

24 hours

 

 

1

1

0

2

1

LC/RE

2

1

0

2

1

RE

3

1

0

2

0

48 hours

 

 

1

1

1

2

1

LC/RE/S/PC

2

1

0

2

1

LC/RE/PC

3

1

0

2

0

LC/PC

72 hours

 

 

1

1

0

2

0

LC/RE/PC

2

1

0

2

1

LC/RE/PC/S

3

1

0

2

0

LC/PC

8 days

 

 

1

0

0

0

0

RE

2

1

1

2

1

LC/RE/PC/MV

3

1

0

2

0

LC/PC

15 days

 

 

1

0

0

0

0

RE

2

2

1

2

1

LC/RE/LC/MV

3

1

0

2

0

LC/PC/MV

21 days

 

 

1

0

0

0

0

RE

2

3

0

2

0

RE/PC/LC/MV

3

1

0

2

0

RE/PC/LC/MV

mean

 

 

1

1

0,3

2

0,7

2

1

0

2

1

3

1

0

2

0

mean

1

0,1

2

0,6

LC: Loss of corneal tissue

MV: Marginal vascularization of the cornea

PC: Pupil contracted

RE: Small Retractions in the eyelids

S: Suppuration

Mean scores calculated for each animal over 24, 48 and 72 hours were 1.0, 1.0 and 1.0 for corneal opacity; 0.33, 0.0 and 0.0 for iris lesions; 2.0, 2.0 and 2.0 for redness of the conjunctiva and 0.66, 1.0 and 0.0 for chemosis.

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 experimental conditions of this study, the test item was found severely irritating to the eye of rabbit. Based on these results, the test item reaction product of naphthalene, butanol, sulfonated and neutralized by caustic soda is classified Xi, R 41, risk of serious damage to eyes, according to Annex VI of the Directive 67/548/CEE, and Eye Damage Cat 1, H318 according to EU Regulation 1272/2008 (CLP), considering the persistence of eye damages at the end of the observation period (21 days).
Executive summary:

The substance has been tested for eye irritation in rabbits, according to O.E.C.D. guideline Nb.405. 0.1 ml of the test article was instilled in the eye of White rabbits (3 animals). Animals were then observed for 21 days. Irritation was scored.

The substance was found to be severely irritating to the eye in the rabbit. Persistence of eye damages at the end of the observation period (21 days) was observed. Mean scores calculated for each animal over 24, 48 and 72 hours were 1.0, 1.0 and 1.0 for corneal opacity; 0.33, 0.0 and 0.0 for iris lesions; 2.0, 2.0 and 2.0 for redness of the conjunctiva and 0.66, 1.0 and 0.0 for chemosis.

Under the experimental conditions of this study, the test item was found severely irritating to the eye of rabbit. Based on these results, the test item reaction product of naphthalene, butanol, sulfonated and neutralized by caustic soda is classified Xi, R 41, risk of serious damage to eyes, according to Annex VI of the Directive 67/548/CEE and Eye Damage, Cat 1, H318 according to EU Regulation 1272/2008 (CLP), considering the persistence of eyes damages at the end of the observation period (21 days).