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EC number: 939-707-2 | CAS number: -
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- Irritation / corrosion
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- Additional toxicological data

Eye irritation
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:
- 1 987
- 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
- 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
Constituent 1
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).
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