Registration Dossier

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:
1996-05-21 to 1996-06-19
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
(1992)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
2,2,4(or 2,4,4)-trimethyl-1,6-hexanediol of Hüls AG
purity 94.6 % (GC-FID area)
batch No. Pt. 15570/3033 of August 1995; sample ID 0637/81 770

Test animals / tissue source

Species:
rabbit
Strain:
other: Small white Russian, Mol:Russian / Chbb: HM
Details on test animals or tissues and environmental conditions:
TEST ANIMALS: 
- Strain: Small white Russian, Mol:Russian / Chbb: HM
- Source: Moellegaard Breeding & Research Cetre Ltd., 4623 Ll.Skensved  (Denmark)
- Sex: male
- Weight at study initiation: 3.2 - 3.3 kg
- Housing: single
- Diet (e.g. ad libitum): Sniff K 4, complete feed for rabbits, Ssniff Spezialfutter GmbH, 59494 Soest, Germany
- Water (e.g. ad libitum): tap water
- Acclimation period: at least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 15 times per hour
- Photoperiod (hrs dark / hrs light): 12 hour light/dark rhythm

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye
Amount / concentration applied:
undiluted test item
Amount applied: 0.1 ml
Duration of treatment / exposure:
24 hour(s)
Observation period (in vivo):
28 days
Number of animals or in vitro replicates:
3
Details on study design:
ADMINISTRATION/EXPOSURE 
- Vehicle: none
- rinsed after 24 hours
- Postexposure observation period: 28 days
EXAMINATIONS
- Ophtalmoscopic examination:  1 and 24, 48, 72 hours, 6, 8, 10, 13, 17, 21, 24 and 28 days  after treatment
- Tool used to assess score: sodium fluorescein / ophthalmic lamp /  visual inspections
- Scoring system: Draize (1959); evaluation: VCI notes on safety data  sheet and Appendix VI of 79/831/EEC

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
not fully reversible within: 28 days
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0.44
Max. score:
2
Reversibility:
not fully reversible within: 28 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 28 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 28 days
Irritant / corrosive response data:
AVERAGE SCORE
- Cornea: 1.33
- Iris: 0.44
- Conjunctivae (Redness): 1.00
- Conjunctivae (Chemosis): 2.00
- Overall irritation score: not reported
REVERSIBILITY: incomplete by day 28 (end of study), i.e. irreversible  damage
Other effects:
OTHER EFFECTS: Typical observations were: exsudation and circumcorneal  hyperemia (1-24 hours); bleeding in eyelids and nictitating membrnes  (24-72 hours); 
slight circumcorneal injection (day 6); recovery

Any other information on results incl. tables

AVERAGE SCORE
- Cornea: 1.33
- Iris: 0.44
- Conjunctivae (Redness): 1.00
- Conjunctivae (Chemosis): 2.00
- Overall irritation score: not reported
REVERSIBILITY: incomplete by day 28 (end of study), i.e. irreversible  damage
OTHER EFFECTS: Typical observations were: exsudation and circumcorneal  hyperemia (1-24 hours); bleeding in eyelids and nictitating membrnes  (24-72 hours); slight circumcorneal injection (day 6); recovery

Applicant's summary and conclusion

Conclusions:
The test substance causes irreversible damage to eyes in a study according to OECD 405 in rabbits.
Executive summary:

This study was performed to examine eye irritating effects of test item according to OECD TG 405 in rabbits. 0.1 ml of undiluted test substance was applied in the conjunctival sac of one eye per animal of three male rabbits with rinsing after 24 hours.

Eye irritation index was assessed using Draize scale. The test was evaluated as follows (average of evaluation at 24, 48 and 72 hours respectively): cornea: 1.33, iris: 0.44, conjunctivae: redness: 1.00 and chemosis: 2.00 (mean scores on Draize scale). Typical observations were: exsudation and circumcorneal  hyperemia (1-24 hours); bleeding in eyelids and nictitating membranes  (24-72 hours);  slight circumcorneal injection (day 6); recovery. The reversibility were incomplete by day 28 (end of study), i.e. irreversible  damage.