3-mercaptopropane-1,2-diol

Endpoint summary

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin 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

Qualifier:

according to guideline

Guideline:

other: 16 CFR 1500.41

Qualifier:

equivalent or similar to guideline

Guideline:

EPA OPP 81-5 (Acute Dermal Irritation)

Deviations:

not specified

GLP compliance:

no

Remarks:

study was conducted prior to the GLP legislation

Specific details on test material used for the study:

Batch 297-1382

Species:

rabbit

Strain:

other: Albino, not further specified

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

24 h

Observation period:

72 h

Number of animals:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not reported

OBSERVATION TIME POINTS
24 + 72 h

SCORING SYSTEM:
Draize

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Remarks on result:

positive indication of irritation

Remarks:

only 24 and 72 h readings wer conducted

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

3.42

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Remarks on result:

positive indication of irritation

Remarks:

only 24 and 72 h readings wer conducted

Irritant / corrosive response data:

Rabbit # Time [h]
erythema oedema
1 24 2 3
72 4 3
average 3.0 3.0
2 24 2 4
72 4 4
average 3.0 4.0
3 24 2 4
72 4 3
average 3.0 3.5
4 24 2 4
72 4 4
average 3.0 4.0
5 24 2 3
72 4 3
average 3.0 3.0
6 24 2 3
72 4 3
average 3.0 3.0

Time [h]
erythema oedema
average 24 2.00 3.50
72 4.00 3.33
24/72 3.00 3.42

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

Based the average erythema and oedema scores of 3.0 and 3.4, respectively, TG should be classified as skin irritant (Skin Irrit 2).

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

other: 16 CFR 1500.42

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

Specific details on test material used for the study:

Batch 297-1382

Species:

rabbit

Strain:

other: Albino, not further specified

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

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0.33

Max. score:

2

Reversibility:

fully reversible within: 7 d

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

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

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based the average skin erythema and oedema scores of 3.0 and 3.4, respectively, TG should be classified as skin irritant (Skin Irrit 2). There were no signs of skin corrosion.

In an eye irritation study (6 rabbits), the average scores (individual and for all 6 animals) are below the CLP criteria for classification as an eye irritant.

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. Thus, TG should not be classified as an eye irritant.