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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1957
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was not performed under GLP compliance, however, the study was conducted according to standards of that time, therefore the study is considered to be adequate, reliable and relevant.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1957
Report date:
1957

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
dose of 0.05mL, observation period of 7 days (not until reversibility), no detailed scoring done
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium 1,4-bis(1,3-dimethylbutyl) sulphonatosuccinate
EC Number:
219-147-9
EC Name:
Sodium 1,4-bis(1,3-dimethylbutyl) sulphonatosuccinate
Cas Number:
2373-38-8
Molecular formula:
C16H30O7S.Na
IUPAC Name:
sodium 1,4-bis[(4-methylpentan-2-yl)oxy]-1,4-dioxobutane-2-sulfonate
Test material form:
liquid: viscous
Details on test material:
- Name of test material (as cited in study report): Aerosol MA-80%, sodium dihexylsulfosuccinate
- Physical state: Clear, viscous liquid (80% solution)
- Analytical purity: 78-80%
- Impurities (identity and concentrations): See confidential details
- Composition of test material, percentage of components: See confidential details
- Purity test date: Not provided
- Lot/batch No.: BV-1193A NH
- Expiration date of the lot/batch: Not provided
- Stability under test conditions: good stability in aqueous solution
- Storage condition of test material: Not provided

Test animals / tissue source

Species:
rabbit
Strain:
other: albino
Details on test animals or tissues and environmental conditions:
Not provided

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.05 mL of Aerosol MA-80%
Duration of treatment / exposure:
The lids of the left eye were held close for 30 seconds following introduction in the eye.
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
5 male albino rabbits

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: at intervals over the next several days
Max. score:
4
Remarks on result:
other: classification (no scores provided in the report)
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: at intervals over the next several days
Max. score:
4
Remarks on result:
other: classification (no scores provided in the report)
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: at intervals over the next several days
Max. score:
4
Remarks on result:
other: classification (no scores provided in the report)
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
other: at intervals over the next several days
Max. score:
4
Remarks on result:
other: classification (no scores provided in the report)
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
other: at intervals over the next several days
Max. score:
4
Remarks on result:
other: classification (no scores provided in the report)
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: at intervals over the next several days
Max. score:
2
Remarks on result:
other: classification (no scores provided in the report)
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: at intervals over the next several days
Max. score:
2
Remarks on result:
other: classification (no scores provided in the report)
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: at intervals over the next several days
Max. score:
2
Remarks on result:
other: classification (no scores provided in the report)
Irritation parameter:
iris score
Basis:
animal #4
Time point:
other: at intervals over the next several days
Max. score:
2
Remarks on result:
other: classification (no scores provided in the report)
Irritation parameter:
iris score
Basis:
animal #5
Time point:
other: at intervals over the next several days
Max. score:
2
Remarks on result:
other: classification (no scores provided in the report)
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: at intervals over the next several days
Max. score:
3
Remarks on result:
other: classification (no scores provided in the report)
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: at intervals over the next several days
Max. score:
3
Remarks on result:
other: classification (no scores provided in the report)
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: at intervals over the next several days
Max. score:
3
Remarks on result:
other: classification (no scores provided in the report)
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
other: at intervals over the next several days
Max. score:
3
Remarks on result:
other: classification (no scores provided in the report)
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
other: at intervals over the next several days
Max. score:
3
Remarks on result:
other: classification (no scores provided in the report)
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: at intervals over the next several days
Max. score:
4
Remarks on result:
other: classification (no scores provided in the report)
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: at intervals over the next several days
Max. score:
4
Remarks on result:
other: classification (no scores provided in the report)
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: at intervals over the next several days
Max. score:
4
Remarks on result:
other: classification (no scores provided in the report)
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
other: at intervals over the next several days
Max. score:
4
Remarks on result:
other: classification (no scores provided in the report)
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
other: at intervals over the next several days
Max. score:
4
Remarks on result:
other: classification (no scores provided in the report)
Irritation parameter:
other: no scores provided in report
Max. score:
4
Remarks on result:
other: classification
Irritant / corrosive response data:
No scores available
Other effects:
There was an immediate reaction of pain, but by four hours after the dose no more serious signs of irritation than profuse discharge was observed. At observation on the following day, the discharge had lessened somewhat, but a moderate degree of conjunctivitis had developed, together with extreme swelling of the lids in two instances. The intensity of these reactions was variable within the group, so that in the case of the two animals noted the severity of irritation was considerably more pronounced than with the others, and, in addition, they displayed signs of corneal involvement characterized by diffuse clouding of the entire area. These differences in response are probably attributable to differences in amount of the dose washed out by the initial discharge. However, by the fourth day the pattern of injury was well-developed in all eyes and consisted of moderate discharge, partial closing of the lids by swelling, moderate conjunctivitis, sluggish reaction of the iris to light, and diffuse corneal opacity. This condition persisted with no appreciable improvement for the reminder of a 7-day observation period.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
In common with other anionic surface-active agents, this test item, as a concentrated solution, is severely irritating to rabbit eyes, producing injury that is slow to heal.
Executive summary:

A volume of approximately 0.05 mL of the test item containing 80% active ingredient was instilled into the conjunctival sac of the left eye of each of 5 male albino rabbits. The lids were held closed for about 30 seconds following introduction of the dose, and the eye was examined immediately thereafter, and again over the next several days. There was an immediate reaction of pain, but by four hours after the dose no more serious signs of irritation than profuse discharge was observed. At observation on the following day, the discharge had lessened somewhat, but a moderate degree of conjunctivitis had developed, together with extreme swelling of the lids in two instances. The intensity of these reactions was variable within the group, so that in the case of the two animals noted the severity of irritation was considerably more pronounced than with the others and, in addition, they displayed signs of corneal involvement characterized by diffuse clouding of the entire area. These differences in response are probably attributable to differences in amount of the dose washed out by the initial discharge. However, by the fourth day the pattern of injury was well-developed in all eyes and consisted of moderate discharge, partial closing of the lids by swelling, moderate conjunctivitis, sluggish reaction of the iris to light, and diffuse corneal opacity. This condition persisted with no appreciable improvement for the reminder of a 7-day observation period. There were no scores available.