2-piperazin-1-ylethanol

Endpoint summary

Description of key information

skin irritation: irritating

eye irritation: irreversible effects

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:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

(occlusive conditions, exposure period up to 20 hours)

GLP compliance:

no

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 3.02 and 3.05 kg

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

undiluted test item applied on dorsal skin

Duration of treatment / exposure:

1, 5 and 15 min and 20 h

Observation period:

8 days

Number of animals:

2 males

Details on study design:

TEST SITE
A cotton pad (2.5x2.5 cm) was covered with the undiluted liquid test substance and was applied under occlusive conditions onto the skin of the back.
REMOVAL OF TEST SUBSTANCE
- Washing: 1x Lutrol and 1x 50% Lutrol
- Time after start of exposure: Immediately after 1, 5 and 15 min exposure.

SCORING SYSTEM: The original BASF grading was converted into the numerical grading according the OECD Draize system.

Irritation parameter:

erythema score

Remarks:

1, 5 or 15 min exposure

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Remarks:

1, 5 or 15 min exposure

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

erythema score

Remarks:

20 h exposure

Basis:

mean

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Irritation parameter:

edema score

Remarks:

20 h exposure

Basis:

mean

Time point:

24/48/72 h

Score:

1.6

Max. score:

4

Reversibility:

fully reversible within: 8 days

Other effects:

No mortality occurred and there were no signs of systemic toxicity from the dermal exposure.

Mean erythema score after 24, 48 and 72 h (animal1/2)

Exposure time	24 h	48 h	72 h	mean
1 min	0/0	0/0	0/0	0/0
5 min	0/0	0/0	0/0	0/0
15 min	0/0	0/0	0/0	0/0
20 h	3/3	3/3	3/3	3/3

Mean edema score after 24, 48 and 72 h (animal1/2)

Exposure time	24 h	48 h	72 h	mean
1 min	0/0	0/0	0/0	0/0
5 min	0/0	0/0	0/0	0/0
15 min	0/0	0/0	0/0	0/0
20 h	2/2	2/2	2/0	2/1.3

20 h treatment: erythema patchy or extending beyond the area of exposure, bleeding, incrustation, scaling.

Interpretation of results:

Category 2 (irritant) based on GHS criteria

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

(only 50 µL of the test substance were used and the observation period was 8 days)

GLP compliance:

no

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 3.28 and 3.24 kg

Vehicle:

unchanged (no vehicle)

Controls:

other: the adjacent eye served as saline-control.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µL undiluted test ietm

Duration of treatment / exposure:

Single application, eyes were not washed out.

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

2

Details on study design:

50 µL of the test substance were applied to the conjunctival sac of one eye in 2 animals. The animals were observed after 10 min, 1 and 3h on the day of treatment and up to 8 days afterwards. The report describes findings after 1 and 24 hours and at the end of the observation period.

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

not fully reversible within: 8 days

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

not fully reversible within: 8 days

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 8 days

Findings: animal1/animal2

Time	opacity	iritis	erythema	chemosis
1 h	3/3	2/2	2/2	1/2
24 h	3/3	2/2	2/2	1/1
48 h	3/3	2/2	2/2	1/1
72 h	3/3	2/2	2/2	1/1
8 d	3/3	2/2	2/2	0/0

The original BASF grading was converted into the numerical grading according the OECD Draize system.

Mean values over 24, 48, and 72 h

Animal 1: Erythema: 2 ; Opacity: 3; Chemosis: 1; Iritis: 2

Animal 2: Erythema: 2 ; Opacity: 3; Chemosis: 1; Iritis: 2

Additional observations: discharge with blood, staphyloma, marginal vascularization of the cornea, small retraction in the eyelid.

Severe corneal opacity and staphyloma formation are regarded as irreversible damage to ophthalmic tissue.

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation

In the key-study similar to OECD TG 404 the skin irritation potential of the test item was assessed. Two rabbits (Vienna White) were shaved and the undiluted liquid test item was applied for 1, 5 and 15 min or 20 h on the back of the animals under occlusive conditions. The observation period was 8 days. Immediately after exposure, the test item was removed by washing with 1x Lutrol and 1x 50% Lutrol. Scoring was done according to Draize. No mortality occurred and there were no signs of systemic toxicity from the dermal exposure. After short exposure times up to 15 min no skin reactions occurred. After 20 h exposure moderate to severe erythema was observed which was not fully reversible within 8 days. In addition, very slight to well-defined edema was observed, which was fully reversible within the observation period. The test item was irritating after 20 h occluded application (BASF, 1968).

In a supporting study according OECD TG 404 (1981) was performed to assess the irritating potential of the test item in vivo. The undiluted test item was applied on the clipped skin of three rabbits using a gauze patch, which was secured in position with a strip of surgical adhesive tape. After 4 hours exposure, the patches were removed and the test material was washed off with a cotton wool soaked in distilled water. Approximately 1 hour after removal, and 24, 48 and 72 hours later, the test sites were examined and scored according to Draize. Very slight to well-defined erythema was noted after 1 hour and 24 hours after patch removal. Very slight erythema was noted at one treatment site at the 48 hour observation and at all treatment sites at the 72-hour observation. Desquamation was noted at all treatment sites at the 7-day observation. Very slight edema was noted at all treatment sites one and 24-hours after patch removal and persisted at two treatment sites at the 48 and 72-hour observations. All reactions were fully reversible within 7 days. Under the conditions chosen in the study the test item was found to be non-irritant (Berol Nobel, 1990).

Eye irritation

In a study similar to OECD TG 405 the potential of the test substance to induce eye irritation was assessed. The test item (50µL) was applied to the conjunctival sac of one eye in each two rabbits (Vienna White) without washing out. The other eye served as saline control. The animals were observed after 10 min, 1h and 3 h on the day of treatment and up to 8 days afterwards. Scoring was converted from the original BASF grading into the numerical grading according to Draize.

Cornea opacity was observed which was not fully reversible after 8 days. The mean value over 24, 48 and 72 h was 3 for opacity in both animals. For erythema and iritis the mean value was 2.0 (not fully reversible after 8 days) and for chemosis 1.0 (fully reversible after 8 days). Additional observations were discharge with blood, staphyloma, marginal vascularization of the cornea, small retraction in the eyelid. Severe corneal opacity and staphyloma formation are regarded as irreversible damage to ophthalmic tissue (BASF AG, 1968).

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the substance is considered to be classified as skin irritant under Regulation (EC) No 1272/2008, as amended for the ninth time in Regulation EC No 2016/1179. Based on the data, the test substance is classified as Skin Irritant Cat. 2 (H315: "Causes Skin Irritation") and Eye Irritant Cat 1 (H318: "Causes serious eye damage") under Regulation (EC) No 1272/2008, as amended for the ninth time in Regulation EC No 2016/1179.