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EC number: 939-603-7 | CAS number: 1471316-72-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 06 Mar - 18 Mar 2008
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study with acceptable restrictions, in some cases the animals had already been used in earlier studies.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- in some cases the animals had already been used in earlier studies.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- in some cases the animals had already been used in earlier studies.
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Ministerium für Umwelt und Naturschutz, Landwirtschaft und Verbraucherschutz des Landes Nordrhein-Westfalen, Düsseldorf, Germany
Test material
- Reference substance name:
- Benzenesulfonic acid, di-C10-14-alkyl derivs., calcium salts
- EC Number:
- 939-603-7
- Cas Number:
- 1471316-72-9
- Molecular formula:
- not applicable (UVCB substance)
- IUPAC Name:
- Benzenesulfonic acid, di-C10-14-alkyl derivs., calcium salts
- Details on test material:
- - Name of test material (as cited in study report): benzenesulfonic acid, di-C10-14-alkyl derivs., calcium salts
- Physical state: liquid, brown
- Analytical purity: 100%
- Lot/batch No.: 06-6923
- Expiration date of the lot/batch: 2008-11-11
- Storage condition of test material: room temperature
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Crl:KBL(NZW)BR
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Kißlegg, Germany
- Age at study initiation: young adult animals (females)
- Weight at study initiation: 2300 - 2600 g
- Housing: individual housing in Metall/Noryl (EBECO) cages, excrement trays below the cages contained low dust wood granulate bedding.
- Diet: standard diet Ssniff (Spezialdiäten GmbH, Soest, Germany), approximately 100 g/animal/day. Hay or hay pellets were offered additionally (hay, irradiated, Harlan Winkelmann GmbH, Borchen Germany; hay pellets, Ssniff Spezialdiäten GmbH, Soest, Germany)
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 50 ± 25
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye served as control
- 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 h
- Observation period (in vivo):
- 7 days
Reading time points: 1, 24, 48 and 72 h and 7 days - Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated eye was rinsed
- Time after start of exposure: 24 h
SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritant / corrosive response data:
- Cornea/Iris: No effects on cornea or iris were observed during the study period in any animal.
Conjunctivae: At the 1 and 24 h reading time point all animals showed moderate conjunctivae redness. After 48 h mild redness was apparent in all animals, still persistent in 2/3 animals after 72 h. All conjunctivae redness was fully reversible within 72 h and 7 days, respectively.
Chemosis: 3/3 animals showed mild swelling after 24 h which was fully reversible in 2/3 animals after 48 h. In 1/3 animals chemosis was persistent up to 72 h and fully reversible after 7 days. - Other effects:
- No further local or systemic effects were reported.
Any other information on results incl. tables
Table 1. Results of eye irritation study.
Rabbit # |
Time [h] |
conjunctivae |
|
iris |
cornea |
redness |
swelling |
||||
1 |
1 |
2 |
0 |
0 |
0 |
24 |
2 |
1 |
0 |
0 |
|
48 |
1 |
0 |
0 |
0 |
|
72 |
1 |
0 |
0 |
0 |
|
168 |
0 |
0 |
0 |
0 |
|
average |
1.3 |
0.3 |
0.0 |
0.0 |
|
2 |
1 |
2 |
0 |
0 |
0 |
24 |
2 |
1 |
0 |
0 |
|
48 |
1 |
1 |
0 |
0 |
|
72 |
1 |
1 |
0 |
0 |
|
168 |
0 |
0 |
0 |
0 |
|
average |
1.3 |
1.0 |
0.0 |
0.0 |
|
3 |
1 |
2 |
0 |
0 |
0 |
24 |
2 |
1 |
0 |
0 |
|
48 |
1 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
average |
1.0 |
0.3 |
0.0 |
0.0 |
|
|
|
||||
Time [h] |
conjunctivae |
|
iris |
cornea |
|
|
redness |
swelling |
|
|
|
mean over |
1 |
2.00 |
0.00 |
0.00 |
0.00 |
24 |
2.00 |
1.00 |
0.00 |
0.00 |
|
48 |
1.00 |
0.33 |
0.00 |
0.00 |
|
72 |
0.67 |
0.33 |
0.00 |
0.00 |
|
24+48+72 |
1.22 |
0.56 |
0.00 |
0.00 |
|
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified - Executive summary:
The study objective was to determine the irritant effects of the target substance on eyes of albino rabbits (strain Crl:KBL(NZW)BR) (Gmelin, 2008). The study was conducted according to OECD TG 405 and GLP and is assigned as Klimish 1. 0.1 mL of the pure liquid test substance was placed into the conjunctival sac of one eye of the first animal after having gently pulled the lower lid away from the eyeball. The lids were gently held together for about one second in order to prevent loss of the test compound. The other eye, which remained untreated, served as control. The eye was rinsed approximately 24 hours following instillation. There was no severe irritation observed in the first animal, therefore two further rabbits were treated in the same manner. Eye irritations were scored and recorded approximately at 1, 24, 48 and 72 hours post application. Irritation indices were observed after 72 h, therefore the animals were monitored on day 7, 14 and 21 after application until the changes had completely subsided. The degree of ocular lesions was recorded as specified by Draize. The body weight of each animal was recorded at the beginning of the study. If clinical findings other than eye irritations occur they were recorded daily.
The mean scores at 24 -h, 48 -h, and 72 -h reading time points were 0.0 for corneal opacity and iritis for three animals. Redness sconjunctivae scores were 1.3, 1.3 and 1.0 and chemosis conjunctivae scores were 0.3, 1.0 and 0.3 for animal 1, 2, and 3, respectively. All irritation reactions were fully reversible within 7 days. There were no systemic intolerance reactions. According to the classification criteria (CLP/GHS), the substance is not irritating to eyes.
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