Amides, C18-unsatd., N,N-bis(hydroxyethyl)

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

other: Title 21, Code of Federal Regulations, 191.11.

Deviations:

no

GLP compliance:

not specified

Species:

rabbit

Strain:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Housing: Screen bottom cages
- Diet (e.g. ad libitum): Laboratory chow, ad libitum
- Water (e.g. ad libitum): ad libitum

Type of coverage:

semiocclusive

Preparation of test site:

other: one abraded area and one intact area

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

0.5 mL (0.5 g) of the 100% concentration of the test substance.

Duration of treatment / exposure:

24 h

Observation period:

24 and 72 h

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: Backs and flanks of the animals were clipped hair free
- Test substance application: 0.5 mL (0.5 g) of the undiluted test substance was applied in an occlusive patch to the abraded and intact areas of the skin, covered with gauze patch by adhesive-tape.
Duration: 24 h
Scoring criteria: According to Draize classification.
Observations: at 24 and 72 h.

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24 and 72 h

Score:

5.5

Max. score:

8

Reversibility:

not fully reversible within: 72 h

Remarks on result:

other: PDII equals average of 24 and 72 h

Irritation parameter:

erythema score

Basis:

animal: 1 to 6

Time point:

24 h

Score:

3

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Remarks on result:

other: similar results for abraded and non-abraded skin

Irritation parameter:

edema score

Basis:

animal: 1 to 6

Time point:

24 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Remarks on result:

other: similar results for abraded and non-abraded skin

Irritation parameter:

erythema score

Basis:

animal: 1 to 6

Time point:

48 h

Remarks on result:

not measured/tested

Irritation parameter:

erythema score

Basis:

animal: 1 to 6

Time point:

72 h

Score:

3

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Remarks on result:

other: similar results for abraded and non-abraded skin

Irritation parameter:

edema score

Basis:

animal: 1 to 6

Time point:

72 h

Score:

3

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Remarks on result:

other: similar results for abraded and non-abraded skin

Irritation parameter:

edema score

Basis:

animal: 1 to 6

Time point:

48 h

Remarks on result:

not measured/tested

Other effects:

None.

Results for the primary skin irritation of the abraded and intact skin at 24 and 72 hrs:

Animal number	24 h		72 h
	Abraded	Intact	Abraded	Intact
1	3-2	3-2	3-3	3-3
2	3-2	3-2	3-3	3-3
3	3-2	3-2	3-3	3-3
4	3-2	3-2	3-3	3-3
5	3-2	3-2	3-3	3-3
6	3-2	3-2	3-3	3-3

Scoring was done similar to the Draize system of classification.

Observations: Moderate to severe erythema and defined edema was observed at 24 h and moderate to severe erythema and moderate edema was observed at 72 h on abraded and intact rabbit skin.

The mean primary skin irritation index obtained = 5.50 (mean of erythema and edema scores at 24 and 72 h).

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

Under the study conditions, the test substance was irritating to skin.

Executive summary:

A study was conducted to assess the irritation potential of the test substance, C18-unsatd. DEA, to rabbit skin in accordance with Title 21, Code of Federal Regulations, 191.11. Six animals were treated with undiluted test substance (0.5 mL or 0.5 g). The treated areas were covered with a semi-occlusive gauze patch and taped to maintain the test substance in contact with the skin for 24 h. The degree of erythema and edema was recorded according to the Draize scoring system after 24 and 72 h. Moderate to severe erythema and defined edema were observed at 24 h and moderate to severe erythema and moderate edema were seen at 72 h on the abraded and intact skin. The mean primary irritation index (PII) was 5.5. Under the study conditions, the test substance was irritating to skin (Casey, 1976).

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:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

other: Title 21, Code of Federal Regulations, 191.11.

Deviations:

no

GLP compliance:

not specified

Species:

rabbit

Strain:

New Zealand White

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL or 0.1 g of the undiluted test substance was instilled into one eye of each rabbit. The other eye served as control.
- Concentration (if solution): 100% (undiluted)

Duration of treatment / exposure:

Single instillation

Observation period (in vivo):

24, 48, 72 h and 7 and 14 d.

Number of animals or in vitro replicates:

Six

Details on study design:

0.1 mL or 0.1 g of the undiluted test substance was instilled into the one eye of each animal, and the other eye served as control. The eyes were evaluated for damage to cornea, iris and bulbar and palpebral conjunctivae at 24, 48 and 72 h and 7 and 14 d after instillation. Any residue of the test substance and accumulated discharge are flushed from the eye each time they are scored.

Irritation parameter:

cornea opacity score

Basis:

animal: 1 to 6

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal: 1 to 6

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

animal: 1 to 6

Time point:

24/48/72 h

Score:

>= 1 - <= 2

Max. score:

2

Reversibility:

not fully reversible within: 14 d

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal: 1 to 6

Time point:

24/48/72 h

Score:

>= 1 - <= 2

Max. score:

2

Reversibility:

not fully reversible within: 14 d

Remarks on result:

positive indication of irritation

Irritation parameter:

overall irritation score

Remarks:

Undiluled test substance

Basis:

animal: 1 to 6

Time point:

24 h

Score:

11.33

Reversibility:

not fully reversible within: 14 d

Irritation parameter:

overall irritation score

Remarks:

Undiluted test substance

Basis:

animal: 1 to 6

Time point:

48 h

Score:

7.67

Reversibility:

not fully reversible within: 14 d

Irritation parameter:

overall irritation score

Remarks:

Undiluted test substance

Basis:

animal: 1 to 6

Time point:

72 h

Score:

5.67

Reversibility:

not fully reversible within: 14 d

Irritation parameter:

overall irritation score

Remarks:

Undiluted test substance

Basis:

animal: 1 to 6

Time point:

7 d

Score:

3.33

Reversibility:

not fully reversible within: 14 d

Irritation parameter:

overall irritation score

Remarks:

Undiluted test substance

Basis:

animal: 1 to 6

Time point:

14 d

Score:

2.33

Reversibility:

not fully reversible within: 14 d

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

Under the study conditions, the undiluted test substance was irritating to eyes.

Executive summary:

The ocular irritation potential of the test substance, C18-unsatd. DEA, was investigated using New Zealand White rabbits in accordance with Title 21, Code of Federal Regulations, 191.11. Undiluted substance (0.1 mL or 0.1 g) was instilled into one eye of each of six rabbits; the other eye served as control. The eyes were evaluated for damage to cornea, iris and conjunctivae at 24, 48, 72 h, then 7 and 14 d. Irritation response in the conjunctiva was observed in terms of redness, chemosis and discharge. The mean conjunctival redness score was 2 in 4/6 animals. The mean irritation score of 11.33, 7.67, 5.67, 3.33 and 2.33 was observed after 24, 48 and 72 h, then 7 and 14 d. Except for conjunctival redness, which was the most prominent response and was present in 3/6 animals, irritation in the remaining eye (chemosis and discharge) reduced to almost 0 by Day 14. Under the study conditions, the test substance was irritating to eyes (Casey, 1976).

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation

A study was conducted to assess the irritation potential of the test substance, C18-unsatd. DEA, to rabbit skin in accordance with Title 21, Code of Federal Regulations, 191.11. Six animals were treated with undiluted test substance (0.5 mL or 0.5 g). The treated areas were covered with a semi-occlusive gauze patch and taped to maintain the test substance in contact with the skin for 24 h. The degree of erythema and edema was recorded according to the Draize scoring system after 24 and 72 h. Moderate to severe erythema and defined edema were observed at 24 h and moderate to severe erythema and moderate edema were seen at 72 h on the abraded and intact skin. The mean primary irritation index (PII) was 5.5. Under the study conditions, the test substance was irritating to skin (Casey, 1976).

Eye irritation

The ocular irritation potential of the test substance, C18-unsatd. DEA, was investigated using New Zealand White rabbits in accordance with Title 21, Code of Federal Regulations, 191.11. Undiluted substance (0.1 mL or 0.1 g) was instilled into one eye of each of six rabbits; the other eye served as control. The eyes were evaluated for damage to cornea, iris and conjunctivae at 24, 48, 72 h, then 7 and 14 d. Irritation response in the conjunctiva was observed in terms of redness, chemosis and discharge. The mean conjunctival redness score was 2 in 4/6 animals. The mean irritation score of 11.33, 7.67, 5.67, 3.33 and 2.33 was observed after 24, 48 and 72 h, then 7 and 14 d. Except for conjunctival redness, which was the most prominent response and was present in 3/6 animals, irritation in the remaining eye (chemosis and discharge) reduced to almost 0 by Day 14. Under the study conditions, the test substance was irritating to eyes (Casey, 1976).

Justification for classification or non-classification

Skin

Based on the results of an in vivo skin irritation study, the substance is irritating to skin. On the basis of this study, the substance was classified as Skin Irrit. 2 - H315 (causes skin irritation) according to CLP (EC 1272/2008) criteria.

Eye

Based on the available in vivo study, undiluted test substance is irritating to eyes. On this basis, the substance was classified as Eye Damage 1 - H318 (causes serious eye damage) according to CLP (EC 1272/2008) criteria.