3-mercaptopropane-1,2-diol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1975

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: 16 CFR 1500.42

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

EPA OPP 81-4 (Acute Eye Irritation)

GLP compliance:

no

Remarks:

study was conducted prior to the GLP legislation

Test material

Test material information

Constituent 1

Reference substance name:

3-mercaptopropane-1,2-diol

EC Number:

202-495-0

EC Name:

3-mercaptopropane-1,2-diol

Cas Number:

96-27-5

Molecular formula:

C3H8O2S

IUPAC Name:

3-sulfanylpropane-1,2-diol

Test material form:

liquid: viscous

Specific details on test material used for the study:

Batch 297-1382

Test animals / tissue source

Species:

rabbit

Strain:

other: Albino, not further specified

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

not reported

Duration of treatment / exposure:

no washout

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

6

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0.33

Max. score:

2

Reversibility:

fully reversible within: 7 d

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

1.83

Max. score:

3

Reversibility:

not fully reversible within: 7 d

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

1.56

Max. score:

4

Reversibility:

not fully reversible within: 7 d

Irritant / corrosive response data:

see table below

Any other information on results incl. tables

Rabbit #	Time [h]	cornea	iris	conjunctivae
				redness	chemosis
1	24	0	0	2	2
	48	0	0	2	1
	72	0	0	2	1
	7 d	0	0	0	1
	average	0.0	0.0	2.0	1.3
2	24	0	1	2	3
	48	0	1	2	3
	72	0	1	2	3
	7 d	0	0	1	1
	average	0.0	1.0	2.0	3.0
3	24	0	1	2	2
	48	0	1	3	2
	72	0	1	3	2
	7 d	0	0	1	1
	average	0.0	1.0	2.7	2.0
4	24	0	0	2	1
	48	0	0	2	1
	72	0	0	1	1
	7 d	0	0	0	0
	average	0.0	0.0	1.7	1.0
5	24	0	0	2	1
	48	0	0	1	1
	72	0	0	1	1
	7 d	0	0	0	0
	average	0.0	0.0	1.3	1.0
6	24	0	0	2	1
	48	0	0	1	1
	72	0	0	1	1
	7 d	0	0	1	0
	average	0.0	0.0	1.3	1.0
	Time [h]	cornea	iris	conjunctivae
				redness	chemosis
average	24	0.00	0.33	2.00	1.67
score	48	0.00	0.33	1.83	1.50
	72	0.00	0.33	1.67	1.50
	24+48+72	0.00	0.33	1.83	1.56

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Conjunctival effects had not completely reversed by Day 7, but an improvement was seen over time. It is expected that all symptoms would have fully reserved within the standard 21-day observation time. The average scores (individual and for all 6 animals) are below the CLP criteria for classification as an eye irritant.