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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP, guideline study
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Remarks:
Not specified in report.
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
-
EC Number:
405-430-6
EC Name:
-
Cas Number:
65143-89-7
Molecular formula:
UVCB
IUPAC Name:
Reaction mass of Benzene sulfonic acid, hexadecyl(sulfophenoxy)-,disodium salt and Benzene sulfonic acid, - oxibis[hexadecyl]-, disodium salt
Test material form:
other: liquid
Details on test material:
Test material: DOWFAX XD 8390 (~37% a.i.)
Source: Dow Chemical Europe
Appearance: brown liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Three young adult female albino rabbits of the New Zealand White strain, SPF quality, were obtained from The Broekman Institute, Someren, The
Netherlands. At the time of arrival at the animal house (18-08-1986), they were 10 to 12 weeks old. The animals, ear-marked 2159, 2163 and 2183, were individually housed in plastic cages with perforated floors. A quarantine period of 7 days was observed. Both eyes were inspected on the day o f
exposure to the test substance and found to be intact and normal. The body weights of the animals were measured on the day of dose administration. They were fed standard laboratory animal diet (100 g per day), obtained from Hope Farms, Woerden (LK-01, pellet diameter 4 mm), and
had free access to tap-water. The animal room temperature was 19-21°C (with the exception of days 7, 8 and 9 o f the study when it dropped down t o 16°C twice) and the relative humidity was between 45 and 80 per cent. The artificial light sequence was 12 hours light, 12 hours dark.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
single instillation
Observation period (in vivo):
Eyes were examined approximately 1, 24, 48 and 72 hours, and 7, 14 and 21 days after instillation of the test substance.
Number of animals or in vitro replicates:
3
Details on study design:
The test substance is applied in a single dose to one of the eyes of the experimental animals; the untreated eye is used to provide control
information. The degree of irritation is evaluated and scored at specific intervals and is further described to provide a complete evaluation of the
toxic effects.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: Corneal opacity
Basis:
mean
Time point:
other: 1, 24, 48 and 72 h and day 7, 14 and 21
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: Very slight corneal opacity present at 1, 24, 48 and 72 h.
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1, 24, 48 and 72 h and day 7, 14 and 21
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
other: conjunctival- redness
Basis:
mean
Time point:
other: 1 h
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
other: conjunctival- redness
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
other: conjunctival- redness
Basis:
mean
Time point:
other: Day 7 and 14
Score:
0.7
Max. score:
3
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
other: conjunctival- redness
Basis:
mean
Time point:
other: Day 21
Score:
0.3
Max. score:
3
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
other: conjunctival- chemosis
Basis:
mean
Time point:
other: 1 h
Score:
2.7
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
other: conjunctival- chemosis
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
other: conjunctival- chemosis
Basis:
mean
Time point:
other: Day 7, 14 and 21
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
In all animals the test compound caused slight injection of the blood vessels of the palpebral conjunctivae and nictating membrane and obvious to severe conjunctival swelling one hour after exposure. The swelling decreased quickly to slight and completely returned to normal on day 7. The conjunctival redness increased to moderate in all animals after 24 hours and persisted until day 3. On day 7 in animals 2159 and 2183, slight reddening was still observed; the exposed eye of animal 2163 had returned to normal. In animal 2183, conjunctival reddening was still present on day 21. A Draize score of 7.3 was calculated according to Draize et al . ( 1944). According to the Kay and Calandra interpretation scheme the test substance should be considered as mildly irritating (M2). Signs of systemic intoxication were not observed. In conclusion, exposure of the rabbit's eye to the test substance induced moderate, reversible conjunctival injury in 2/3 rabbits with 1/3 showing persistent damage at Day 21. Based on criteria, the test substance should be labelled as an eye-irritant.
Other effects:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
Category I
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Dowfax XD 8390 was considered an eye irritant.
Executive summary:

The acute eye irritation/corrosion potential of DOWFAX 8390, ~37% a.i., was evaluated by instilling 0.1 ml of the test substance into one of the eyes of three female rabbits. Instillation of DOWFAX 8390, into the eyes resulted in corneal epithelial erosion which healed within 7 days, as well as moderate conjunctival reddening after initial marked chemosis. Damage persisted in one animal as slight conjunctival redness at Day 21, the effects were reversible within 21 days two other animals.