3-hydroxy-2,2-dimethylpropyl 3-hydroxy-2,2-dimethylpropionate

Eye irritation

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

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

(scorring system); BASF-Test

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

3-hydroxy-2,2-dimethylpropyl 3-hydroxy-2,2-dimethylpropionate

EC Number:

214-222-2

EC Name:

3-hydroxy-2,2-dimethylpropyl 3-hydroxy-2,2-dimethylpropionate

Cas Number:

1115-20-4

Molecular formula:

C10H20O4

IUPAC Name:

3-hydroxy-2,2-dimethylpropyl 3-hydroxy-2,2-dimethylpropanoate

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

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.7

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.7

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 8 days

Results 5

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2.3

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Results 6

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.7

Max. score:

3

Reversibility:

not fully reversible within: 8 days

Results 8

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 8 days

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

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.