Registration Dossier

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:
other: see 'Remark'
Remarks:
The study is comparable to OECD Guideline 405 with acceptable restrictions (partly limited documentation, e.g. no details about the test substance; only 50 mg instead of 100 mg test substance instilled; not washed out but comparison with talcum powder was given; max. observation period only 8 days, 21 days recommended).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1974

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
(scorring system); BASF-Test
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Hydroxypivalinsaeureneopentylglykolester (HPN)
- Physical state: solid
no further data

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
Two males, initial bw 3.07 or 3.17 kg
no further details

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: same amount talcum powder into the conjunctival sac of the left eye
Amount / concentration applied:
ca. 50 mg instilled into the conjunctival sac
Duration of treatment / exposure:
unwashed
Observation period (in vivo):
up to 8 days after application; see Table in the result section.
Number of animals or in vitro replicates:
2
Details on study design:
The animals were observed several times on the treatment day and up to 8 days afterwards, and findings were recorded on working days.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24/48/72 h
Score:
1.7
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: observation up to day 8
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
other: observation up to day 8
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24/48/72 h
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: observation up to day 8
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: observation up to day 8
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24/48/72 h
Score:
2.3
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: observation up to day 8, score at day 8: 3
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
other: observation up to day 8
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24/48/72 h
Score:
1.7
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: observation up to day 8
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: observation up to day 8
Irritant / corrosive response data:
Scar formation was observed at day 6 in animal #1; ciliary injection at day 6 and scar formation at day 8 was observed in animal #2.
Small effects were also detected in the left eye (talcum control; mechanical irritation): slight redness (Draize conjunctivae score 1) which was completely reversible within 6 days (animal #1) and 24 h (animal #2).
Other effects:
no effects on body weight
no further data

Any other information on results incl. tables

Eye irritation in 2 rabbits after instillation of 50 mg test substance
Scoring according to OECD-Draize scheme; description of effects from raw data

Time period after application

Rabbit 1

Rabbit 2

Erythema

1 h

1

1

24 h

2

1

48 h

2

2

72 h

1

2

6 days

1

1

8 days

0

1

Time period after application

Rabbit 1

Rabbit 2

Edema

1 h

2

1

24 h

1

2

48 h

0

2

72 h

0

2

6 days

0

1

8 days

0

1

Time period after application

Rabbit 1

Rabbit 2

Corneal opacity and other effects

1 h

1 (discharge)

1

24 h

2 (discharge)

1

48 h

2 (cornea covered by a smeary film)

2 (discharge)

72 h

2 (cornea covered by a smeary film)

2 (ulceration)

6 days

2 (scar formation)

2 (ciliary injection)

8 days

1 (scar formation)

2 (scar formation)

Raw data not clearly compatible with results described in the summary protocol

Applicant's summary and conclusion

Interpretation of results:
highly irritating
Remarks:
Migrated information
Conclusions:
The instillation of 50 mg test substance into the conjunctival sac of rabbit eyes resulted in irreversible effects.
Executive summary:

The study is comparable to OECD Guideline 405 with acceptable restrictions (partly limited documentation, e.g. no details about the test substance; only 50 mg instead of 100 mg test substance instilled).

An amount of 50 mg test substance was instilled into the right eye of 2 rabbits; the left eye served as control (50 mg talcum powder instilled). Effects were recorded 1, 24, 48, 72 h and up to 8 days after instillation. Edema and corneal opacity OECD score 2 were reported in both rabbits as well as ulceration (one rabbit) and scar formation (both rabbits). Corneal opacity was still present in both rabbits 8 days after instillation.

Conclusion: The instillation of 50 mg test substance into the conjunctival sac of the rabbit eyes resulted in irreversible effects.