Sodium (xylenes and 4-ethylbenzene)sulfonates

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:

1975

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

Test material information

Constituent 1

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

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

Results

Results 1

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

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible within: 72 hours

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

5

Max. score:

20

Reversibility:

fully reversible within: 72 hours

Results 4

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).