Sodium glycinate

Endpoint summary

Description of key information

The test material (beta-alanine) produced a Erythema score and Oedema score of 0.0 and was classified as nonirritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.

No corneal or iridial effects were noted with the test material (beta-alanine). Moderate conjunctival irritation was noted in both treated eyes one hour after treatment with minimal conjunctival irritation noted at the 24-hour observation. Both treated eyes appeared normal at the 48-hour observation.

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

See read across document in section 13

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Sponsor's identification: β-Alanine
Description : white crystalline solid
Batch number : 102657
Date received : 20 April 2010
Expiry date : 20 April 2013
Storage conditions: room temperature in the dark over silica gel

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Animals and Animal Husbandry
Two New Zealand White rabbits were supplied by Harlan Laboratories U.K. Ltd., Loughborough, UK. At the start of the study the animals weighed 2.09 or 2.16 kg and were twelve to twenty weeks old. After an acclimatisation period of at least five days each animal was given a number unique within the study which was written with a black indelible marker-pen on the inner surface of the ear and on the cage label.

The animals were individually housed in suspended cages. Free access to mains drinking water and food (2030 Teklad Global Rabbit diet supplied by Harlan Laboratories U.K. Ltd., Oxon, UK) was allowed throughout the study. The diet and drinking water were considered not to contain any contaminantof a level that might have affected the purpose or integrity of the study.

The temperature and relative humidity were set to achieve limits of 17 to 23°C and 30 to 70% respectively. Any occasional deviations from these targets were considered not to have affected the purpose or integrity of the study. The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.

The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

other: test material moistened with distilled water

Amount / concentration applied:

0.5g of test material moistened with 0.5mL of distilled water.

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

2

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: No evidence of skin irritation

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: No evidence of irritation

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: No evidence of irritation

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: No evidence of irritation

Irritant / corrosive response data:

No evidence of skin irritation was noted during the study.

Interpretation of results:

GHS criteria not met

Remarks:

Not irritating

Conclusions:

The test material produced is not irritanting to the skin of the rabbit according to the Draize classification scheme. No corrosive effects were noted.

Executive summary:

A single 4-Hour, semi-occluded application of the test material to the intact skin of two rabbits produced no evidence of skin irritation. 

The test material produced is not irritanting to the skin of the rabbit according to the Draize classification scheme. No corrosive effects were noted.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

See read across document in section 13

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

β-Aminopropionic acid / 107-95-9 / 203-536-5

Species:

rabbit

Strain:

New Zealand White

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

A volume of 0.1 mL of the test material was placed into the conjunctival sac of the right eye.

Duration of treatment / exposure:

72 hours

Observation period (in vivo):

1, 24, 48, and 72 hours following treatment.

Number of animals or in vitro replicates:

2 rabbits were tested in total.

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects observed

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects observed

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: no effects observed

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: no effects observed

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: conjunctival redness observed at 1 hour observation

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: conjunctival redness observed at 1 hour observation

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: conjunctival redness observed at 1 hour observation

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: conjunctival redness observed at 1 hour observation

Irritant / corrosive response data:

Ocular Reactions
No corneal or iridial effects were noted during the study.
Moderate conjunctival irritation was noted in both treated eyes one hour after treatment with minimal conjunctival irritation noted at the 24-hour observation.
Both treated eyes appeared normal at the 48-hour observation.

Interpretation of results:

GHS criteria not met

Conclusions:

The test material produced a maximum group mean score of 9.0 and was classified as a minimal irritant (Class 3 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system. However, the cornea and iris scores were=0 in both animals, the chemosis score was =0.33 in one animal and =0 in the second animals, and redness score was 0.33 in both animals. On the basis of the results of the study, beta-alanine has not to be classified as irritating for eye according to DSD and CLP classification criteria.

Executive summary:

A single application of the test material to the non-irrigated eye of two rabbits produced moderate conjunctival irritation. Both treated eyes appeared normal at the 48-hour observation.

The test material produced a maximum group mean score of 9.0 and was classified as a minimal irritant (Class 3 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system However, the cornea and iris scores were=0 in both animals, the chemosis score was =0.33 in one animal and =0 in the second animals, and redness score was 0.33 in both animals. On the basis of the results of the study, beta-alanine has not to be classified as irritating for eye according to DSD and CLP classification criteria.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)