2-piperidinoethanol

Endpoint summary

Description of key information

Skin irritation / corrosion: corrosive (cat. 1B)

Eye irritation: irreversible damage (cat. 1)

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: well-documented, scientifically acceptable study report

Principles of method if other than guideline:

according to BASF-internal standard

GLP compliance:

no

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

- Source: Gaukler, 6050 Offenbach/Main, Germany
- Acclimatization period: about 8 days before study start (same housing conditions as during the study).
- Single housing in stainless steel cages (floor area: 40 x 51 cm).
- Animal identification: via ear tattoo (= animal number).
- Room temperature: 20 - 26°C
- Relative humidity: 50 - 80%
- Day/night rhythm: 12 h light and 12 h darkness
- The rabbits were offered a standardized animal laboratory diet (about 130 g/animal/day) as well as tap water (about 250 ml/animal/day).

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin of the same animal

Amount / concentration applied:

Test patches with ca. 0.5 ml of the undiluted test substance.

Duration of treatment / exposure:

1 hour

Observation period:

8 days

Number of animals:

2

Details on study design:

- Clipping of the fur: at least 15 hours before application of the test substance
- Application area: 2.5 x 2.5 cm
- Application site: upper third of the back
- After an exposure time of 1 h the test substance was washed off with Lutrol and Lutrol/water (1:1).
- Readings: 15 - 30 minutes after removal of the test patches and 24, 48 h and 8 d after application.
- Scoring according to J.H. Draize, 1959
- In the case of clinical evidence to necroses, the skin was cutted to allow a detailled macroscopical examination.

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48 h

Score:

3

Max. score:

4

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48 h

Score:

0.5

Max. score:

4

Reversibility:

not reversible

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48 h

Score:

1

Max. score:

4

Reversibility:

not reversible

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

After 8 days, the animals showed parchment-like and leather-like necrosis which was confirmed macroscopically by a pathologist.

Interpretation of results:

Category 1 (corrosive) based on GHS criteria

Reference 2

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: well-documented, scientifically acceptable study report

Principles of method if other than guideline:

according to BASF-internal standard

GLP compliance:

no

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

- Source: Gaukler, 6050 Offenbach/Main, Germany
- Acclimatization period: about 8 days before study start (same housing conditions as during the study).
- Single housing in stainless steel cages (floor area: 40 x 51 cm).
- Animal identification: via ear tattoo (= animal number).
- Room temperature: 20 - 26°C
- Relative humidity: 50 - 80%
- Day/night rhythm: 12 h light and 12 h darkness
- The rabbits were offered a standardized animal laboratory diet (about 130 g/animal/day) as well as tap water (about 250 ml/animal/day).

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin of the same animal

Amount / concentration applied:

Test patches with the 0.5 ml of the undiluted test substance.

Duration of treatment / exposure:

4 hours

Observation period:

8 days

Number of animals:

2

Details on study design:

- Clipping of the fur: at least 15 hours before application of the test substance
- Application area: 2.5 x 2.5 cm
- Application site: upper third of the back
- After an exposure time of 4 h the test substance was washed off with Lutrol and Lutrol/water (1:1).
- Readings: 15 - 30 minutes after removal of the test patches and 24, 48 h and 8 d after application.
- Scoring according to J.H. Draize, 1959
- In the case of clinical evidence to necroses, the skin was cutted to allow a detailled macroscopical examination.

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: corrosive

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48 h

Score:

3

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: corrosive

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 8 d

Remarks on result:

positive indication of irritation

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

After 48 hours, the animals showed parchment-like necrosis that developed into deep necrosis within 8 days.

Interpretation of results:

Category 1 (corrosive) based on GHS criteria

Reference 3

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: well-documented, scientifically acceptable study report

Principles of method if other than guideline:

according to BASF-internal standard

GLP compliance:

no

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

- Source: Gaukler, 6050 Offenbach/Main, Germany
- Acclimatization period: about 8 days before study start (same housing conditions as during the study).
- Single housing in stainless steel cages (floor area: 40 x 51 cm).
- Animal identification: via ear tattoo (= animal number).
- Room temperature: 20 - 26°C
- Relative humidity: 50 - 80%
- Day/night rhythm: 12 h light and 12 h darkness
- The rabbits were offered a standardized animal laboratory diet (about 130 g/animal/day) as well as tap water (about 250 ml/animal/day).

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin of the same animal

Amount / concentration applied:

Test patches with ca. 0.5 ml of the undiluted test substance.

Duration of treatment / exposure:

3 minutes

Observation period:

8 days

Number of animals:

2

Details on study design:

- Clipping of the fur: at least 15 hours before application of the test substance
- Application area: 2.5 x 2.5 cm
- Application site: upper third of the back
- After an exposure time of 3 min the test substance was washed off with Lutrol and Lutrol/water (1:1).
- Readings: 15 - 30 minutes after removal of the test patches and 24, 48 h and 8 d after application.
- Scoring according to J.H. Draize, 1959
- In the case of clinical evidence to necroses, the skin was cutted to allow a detailled macroscopical examination.

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible within: 8 d

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible within: 8 d

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Interpretation of results:

study cannot be used for classification

Conclusions:

No indictation of irritating effects after an exposure period of 3 minutes.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study need not be conducted because the available information indicates that the criteria are met for classification as corrosive to the skin or irritating to eyes

Endpoint conclusion

Endpoint conclusion:

no study available

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation / corrosion

In well-documented, scientifically acceptable studies (non-guideline, non-GLP) the undiluted test substance was applied to the intact clipped skin (back) of Vienna White rabbits (2 female animals in each case). After an exposure period of 3 minutes, 1 and 4 hours (occlusive coverage) the test substance was washed of and the degree of skin irritation/corrosion was evaluated according to Draize at different time points (15 - 30 minutes after removal of the test patches and 24, 48 h and 8 d after application).

24 hours after the application of the test substance (1 h exposure period) erythemas occurred developing into severe necroses within further 24 hours that were not reversible. Simultaneously only slight edemas were observed.

An exposure period of 4 hours caused parchment-like necrosis 48 hours after application of the test substance, that developed into deep necrosis within 8 days.

No indication of any irritating effects was observed after 3 min exposure to the test substance.

Taking together these 3 studies, it can be concluded that the test substance has to be classified as skin corrosive Cat. 1B.

Eye irritation

Due to the skin corrosivity of the test substance an eye irritation study has not to be conducted according to Regulation No. 1907/2006 and corrosivity to the eye is assumed as well.

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance has to be classified for skin corrosivity Cat. 1B and eye damage Cat. 1 under Regulation (EC) No. 1272/2008, as amended for the 13th time in Regulation (EU) 2018/1480.