2-aminopropane-1,3-diol

Endpoint summary

Description of key information

Skin: not irritating
Eye: corrosive

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:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

other: 40 CFR, Part 798, Subpart E Section 798.4470, Toxic Substances Control Act, 1994

Deviations:

no

GLP compliance:

not specified

Species:

rabbit

Strain:

not specified

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

other: test substance was slightly moistened with USP 0.9% sodium chloride for injection

Controls:

other: Adjacent areas of untreated skin served as control sites

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g, slightly moistened with USP 0.9% sodium chloride for injection

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: Approximately 6 cm²

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test sited were wiped clean.
- Time after start of exposure: 4 hours.

SCORING SYSTEM:
Performed according to the Draize method

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of all 6 animals

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: reversibility not applicable

Irritation parameter:

edema score

Basis:

mean

Remarks:

of all 6 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Irritant / corrosive response data:

None of the test animals exhibited signs of erythema or edema during the 72 hour observation period. All the scores were 0 at all reading time points.

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified

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

Study period:

1995

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

other: 40 CFR, Part 798, Subpart E Section 798.4500, Toxic Substances Control Act, 1985

Deviations:

no

GLP compliance:

not specified

Species:

rabbit

Strain:

not specified

Vehicle:

unchanged (no vehicle)

Controls:

other: the right, untreated eye served as a control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:

Test substance was not washed from the eye after administration

Observation period (in vivo):

96 hours

Number of animals or in vitro replicates:

6

Details on study design:

SCORING SYSTEM:
The eyes were examined at 1, 24, 48, 72 and 96 hours after administration and scored according to the Draize method for scoring ocular lesions

TOOL USED TO ASSESS SCORE: fluorescein

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

probability of severe irritation

Remarks:

The substance was considered to be corrosive.

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

probability of severe irritation

Remarks:

The substance was considered to be corrosive.

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

probability of severe irritation

Remarks:

The substance was considered to be corrosive.

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

probability of severe irritation

Remarks:

The substance was considered to be corrosive.

Irritation parameter:

other: pannus (corneal vascularisation)

Basis:

other: 4/6 animals

Time point:

other: 96 hours

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: The study was terminated when pannus was observed. The substance was considered to be corrosive.

Irritant / corrosive response data:

All six test animals exhibited positive scores for irritation. Fluorescein staining was observed in 5/6 animals. In addition 4/6 animals developed pannus (corneal vascularization) by the 96-hour observation point. The study was terminated when pannus was observed. The control eye of all animals was normal (grade 0) throughout the observation period.

Interpretation of results:

corrosive

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: Cat. 1, H318
DSD: Xi, R41

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

A skin irritation study (Lister, 1995c) was performed according to 40 CFR, Part 798, Subpart E Section 798.4470, Toxic Substances Control Act, 1994). The test substance was applied to the shaved skin of 6 rabbits and covered with a semi-occlusive dressing for 4 hours. None of the 6 test animals exhibited any signs of erythema or edema during the 72-hour observation period.

These findings were confirmed in the acute dermal toxicity study performed by Lister (1995). In this study APD was administered to rats as a single dose of 2000 mg/kg bw under occlusive conditions for 24 hours.

Therefore, APD is considered not to cause skin irritation under the conditions of these studies.

An eye irritation study was performed using the test substance on rabbits, according to 40 CFR, Part 798, Subpart E Section 798.4500, Toxic Substances Control Act, 1985 (Lister, 1995d). APD was instilled into the eye of the animals and left without washing the eye at any time point. All 6 animals exhibited irritation of the exposed eye and 4/6 developed pannus (corneal vascularisation) within 96 hours. As this is an irreversible effect, the study was terminated after 96 hours. In conclusion, the substance was corrosive to the eye under the conditions of this study.

Effects on eye irritation: corrosive

Justification for classification or non-classification

The available data on skin irritation of the test substance do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification. The available data on eye irritation of the test substance meet the criteria for classification as Category 1 (H318) according to Regulation (EC) 1272/2008 and as Xi R41 according to Directive 67/548/EEC.