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Registration Dossier
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EC number: 701-037-1 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Federal Hazardous Substance Act (FHSA)
- Version / remarks:
- Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics Assoc, Food and Drug Officials of the US, 2nd printing, Topeka, Kansas, 1965. In accordance with Section 1500.42 Chapter 2, Title 16 Code of Federal Regulations under the Federal Hazardous Substances Act
- Principles of method if other than guideline:
- 6 animals; eyes examined with Fluorescein 72 hours before testind; test substance instilled into the conjuntival sac of one eye in each animal; washedout at 24 hours; evaluated at 1, 24, 48 and 72hours
- GLP compliance:
- no
Test material
- Reference substance name:
- Sodium (xylenes and 4-ethylbenzene) sulfonates
- EC Number:
- 701-037-1
- Cas Number:
- 1300-72-7
- Molecular formula:
- -
- IUPAC Name:
- Sodium (xylenes and 4-ethylbenzene) sulfonates
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: individually housed in metal cages elevated above the droppings
- Diet: ad libitum (Purina Rabbit Chow)
- Water : tap water ad libitum
- Acclimation period: at least 72 hours
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): undiluted
VEHICLE
- Amount(s) applied (volume or weight with unit): no vehicle - Duration of treatment / exposure:
- single application, washed out after 24 hours
- Observation period (in vivo):
- 1, 24, 48 and 72 hours
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): washing at 24 hours
SCORING SYSTEM: scale for scoring ocular lesions as outlined by Lehman et al (Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics Assoc, Food and Drug Officials of the US, 2nd printing, Topeka, Kansas, 1965. In accordance with Section 1500.42 Chapter 2, Title 16 Code of Federal Regulations under the Federal Hazardous Substances Act
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 5
- Max. score:
- 20
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Irritant / corrosive response data:
- Maximum mean total score at 1 hr = 13.0, at 24 hr = 12.2, at 48 hr = 5.0 and at 72 hr = 2.0
Slight eye damage in the form of moderate erythema of the palpebral and bulbar conjunctivae, a slight chemosis of the lids, a slight acccumulation of mucoid discharge and a slight to moderate corneal opacity involving one-fourth or less of the corneal surface (4 test eyes only).
Any other information on results incl. tables
See attached table
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Irritant
- Executive summary:
The eye irritation of Sodium (xylenes and 4-ethylbenzene) sulfonates was assessed following official guideline Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics Assoc, in accordance with Section 1500.42 Chapter 2, Title 16 Code of Federal Regulations under the Federal Hazardous Substances Act. The results showed slight eye damage in the form of moderate erythema of the palpebral and bulbar conjunctivae, a slight chemosis of the lids, a slight acccumulation of mucoid discharge and a slight to moderate corneal opacity involving one-fourth or less of the corneal surface (4 test eyes only).
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