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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:
From 24 Jan, 1994 to 14 Feb, 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Esterification products of acrylic acid and 2,2,2',2'-tetrakis(hydroxymethyl)-3,3'-oxydipropan-1-ol
EC Number:
800-838-4
Cas Number:
1384855-91-7
Molecular formula:
Molecular formula not available for this UVCB.
IUPAC Name:
Esterification products of acrylic acid and 2,2,2',2'-tetrakis(hydroxymethyl)-3,3'-oxydipropan-1-ol
Test material form:
liquid: viscous
Details on test material:
- Name of test material (as cited in study report): SR 399
- Physical state: Viscous liquid
- Analytical purity: Not known to HRC
- Lot/batch No.: HYH1309
- Expiration date of the lot/batch: January 1995
- Stability under test conditions:
- Storage condition of test material: Room temperature in the dark
- Date received: 14 December 1993

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Froxfield (U.K.) Ltd., Petersfield, Hampshire, England.
- Age at study initiation: 12 to 14 weeks
- Weight at study initiation: 2.8 to 3.2 kg
- Housing: Individually in plastic cages with perforated floors in Building R 14 Room 1.
- Diet: SDS Stanrab (P) Rabbit Diet (ad libitum)
- Water: Ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: 19°C
- Humidity: 30-70%
- Air changes: 19 air changes/h
- Photoperiod: 12 h of artificial light (0700 - 1900 h) in each 24 h period

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
Duration of treatment / exposure:
Single exposure
Observation period (in vivo):
14 d
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No

TOOL USED TO ASSESS SCORE: Handheld light.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 1
Max. score:
4
Reversibility:
fully reversible within: 14 d
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
2
Reversibility:
other: No adverse effects were observed.
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 1.33
Max. score:
3
Reversibility:
fully reversible within: 14 d
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0.67
Max. score:
4
Reversibility:
fully reversible within: 14 d
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 1
Max. score:
4
Reversibility:
fully reversible within: 14 d
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
2
Reversibility:
other: No adverse effects were observed.
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 1.67
Max. score:
3
Reversibility:
fully reversible within: 14 d
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 1.67
Max. score:
4
Reversibility:
fully reversible within: 14 d
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 1
Max. score:
4
Reversibility:
fully reversible within: 14 d
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
2
Reversibility:
other: No adverse effects were observed.
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 1.67
Max. score:
3
Reversibility:
fully reversible within: 14 d
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 1
Max. score:
4
Reversibility:
fully reversible within: 14 d
Irritant / corrosive response data:
Corneal opacities developed in all three animals. No iridial inflammation was observed. A diffuse crimson red colouration of the conjunctivae accompanied by swelling with partial eversion of the eyelids or with the eyelids about half closed was seen in all three animals. The eyes were normal 7 or 14 d after instillation.

Any other information on results incl. tables

There were no signs of toxicity or ill health in any rabbit during the observation period.

Applicant's summary and conclusion

Interpretation of results:
other: Category 2 (irritating to eyes) based on EU CLP criteria
Conclusions:
Under the study conditions, the test substance was determined to irritating to the eye.
Executive summary:

A study was conducted to determine the eye irritation potential of test substance, DPHA to the rabbit according to EU Method B.5 in compliance with GLP.  Three rabbits were each administered a single ocular dose of 0. 1 mL of the test substance in one eye, whereas contralateral eye remained untreated and observed for a maximum of 14 d after instillation. All animals were observed daily for signs of ill health and toxicity. Examination of the eye was made after 1 h and 1, 2 and 3 days after instillation (24, 48 and 72 h). Additional observations were made 4, 7 and 14 days after instillation. Observations of the eyes was aided by the use of a handheld light. Ocular irritation was assessed using the numerical grading system. There were no signs of toxicity or ill health in any rabbit during the observation period. Corneal opacities developed in all animals. No iridial inflammation was observed. A diffuse crimson red colouration of the conjunctivae accompanied by swelling with partial eversion of the eyelids or with the eyelids about half closed was seen in all three animals. The eyes were normal 7 or 14 d after instillation. Under the study conditions, the test substance was determined to be irritating to the eye (Parcell, 1994).