Registration Dossier
Registration Dossier
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EC number: 273-234-6 | CAS number: 68953-96-8 This substance is identified by SDA Substance Name: C11-C13 branched alkyl benzene sulfonic acid calcium salt and SDA Reporting Number: 25-097-06.
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP laboratory study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: FHSA/CPSC Design, 16 CR 1500
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Branched CaDDBS
- IUPAC Name:
- Branched CaDDBS
- Reference substance name:
- Bubate 401-A
- IUPAC Name:
- Bubate 401-A
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kuiper Rabbitry, Gary, Indiana
- Age at study initiation: 8 to 10 weeks old
- Weight at study initiation: Not stated
- Housing: Individually housed in stainless steel cages in a temperature, humidity and light controlled room in accordance with the recommendations contained in the National Academy Press 1996 "Guide for the Care and Use of Laboratory Animals."
- Diet (e.g. ad libitum): ad libitum Purina Rabbit Chow
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 4 days
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 instilled directly into the eye
- Concentration (if solution): undiluted
The contralateral eye served as the untreated control for each rabbit - Duration of treatment / exposure:
- See observation period. Not rinsed.
- Observation period (in vivo):
- The eyes were examined at 1, 24, 48, 72, 168 and 336 hours after treatment. At these intervals the extent and degree of irritation were scored.
- Number of animals or in vitro replicates:
- Three
- Details on study design:
- SCORING SYSTEM: As per Draize et al. 1944 scoring system and the FHS Labeling Act Regulations Guide for Grading Eye Irritation.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 336 hours
- Score:
- 89.4
- Max. score:
- 110
- Reversibility:
- not reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 91.1
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 12.8
- Reversibility:
- not reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 15.3
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Irritant / corrosive response data:
- Instillation of the test material into the eyes of rabbits produced positive eye irritation reactions in all three of the test subjects. The maximum group mean score was 89.4/110.0 at the 336 hour observation.
Any other information on results incl. tables
Mean Score
Hours after Treatment |
1 |
24 |
48 |
72 |
168 |
336 |
Cornea (D-A) |
- |
33.3 |
40.0 |
40.0 |
46.7 |
66.7 |
Iris |
5.0 |
5.0 |
5.0 |
8.3 |
8.3 |
10.0 |
Conjunctiva (R-S-D) |
15.3 |
14.7 |
15.3 |
16.0 |
14.0 |
12.7 |
Total |
20.3 |
53.0 |
60.3 |
64.3 |
69.0 |
89.4 |
Maximum Group Mean Score: 89.4/110.0 at 336 hours
Applicant's summary and conclusion
- Interpretation of results:
- highly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Ninate 401-A is extremely irritating.
- Executive summary:
The test substance, Ninate 401A, was tested for eye irritation in accordance with FHSA/CPSC guidelines. The sample was applied at a dose of 0.1 mL undiluted to one eye in each of three albino rabbits. Eyes were graded at 1, 24, 48, 72, 168 and 336 hours. There were positive eye irritation reactions in all of the three test animals. The maximum group mean score was 89.4/110.0 at the 336 hour observation. Ninate 401A is classified as extremely irritating.
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