Rape oil, reaction products with diethanolamine

Endpoint summary

Description of key information

The available data suggests that the structural analogue amides, C18-unsatd., N,N-bis(hydroxyethyl) is expected to be irritating to both the skin and the eyes. On this basis, it is assumed that HE Rape Oil, reaction product with diethanolamine will be irritating to both the skin and the eyes also.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was conducted on the structural analogue amides, C18(unsatd.), N,N-bis(hydroxyethyl) in accordance with Title 21, Code of Federal Regulations, 191.11.

Reason / purpose for cross-reference:

reference to same study

Qualifier:

according to guideline

Guideline:

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

Principles of method if other than guideline:

None

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 aread 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:

Six

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:

no data

Remarks on result:

other: irritating to the skin (mean of erythema and edema scores at 24 and 72 h).

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)

Remarks:

Migrated information irritating to the skin Criteria used for interpretation of results: EU

Conclusions:

Under the test conditions, the test substance had an irritant effect on the skin and was classified as a irritating according to the definitions given in the U.S. Federal Hazardous Substances Act. The Draize system of classification, which is separate from the Federal Register test, would regard the test substance as a severe irritant to the skin. Further, according to CLP criteria (EC 1272/2008) , the test substance may be considered to be Category 2 skin irritant as the mean scores of erythema and edema were >2.3 after 72 h.

Executive summary:

A study was conducted to assess the skin irritation potential of test substance, amides, C18 -unsatd., N,N-bis(hydroxyethyl) to the rabbit skin in accordance with Title 21, Code of Federal Regulations, 191.11.

Six animals were treated with undiluted 0.5 mL (0.5 g) of the test substance. The treated areas were covered with a semi-occlusive gauze patch and taped to maintain the test substance in contact with the skin for a duration of 24 h. The degree of erythema and edema were recorded according to Draize scoring system after 24 and 72 h.

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 the abraded and intact rabbit skin. The meanprimary skin irritation index (PII) was 5.5.

Under the test conditions, the test substance had an irritant effect on the skin and was classified as a irritating according to the definitions given in the U.S. Federal Hazardous Substances Act. The Draize system of classification, which is separate from the Federal Register test, would regard the material as a severe irritant to the skin. Further, According to CLP criteria (EC 1272/2008), the test substance may be considered to be Category 2 skin irritant as the mean scores of erythema and edema were >2.3 after 72 h.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was conducted on the structural analogue amides, C18(unsatd.), N,N-bis(hydroxyethyl) in accordance with Title 21, Code of Federal Regulations, 191.11.

Reason / purpose for cross-reference:

reference to same study

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

not specified

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

None

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:

maximum mean total score (MMTS)

Basis:

mean

Time point:

other: 24 h

Score:

11.33

Reversibility:

not specified

Remarks on result:

other: irritating according to CLP (self classified)

Irritation parameter:

maximum mean total score (MMTS)

Remarks:

:Undiluted test substance

Basis:

mean

Time point:

other: 48 h

Score:

7.67

Reversibility:

not specified

Remarks on result:

other: irritating according to CLP (self classified)

Irritation parameter:

maximum mean total score (MMTS)

Remarks:

:Undiluted test substance

Basis:

mean

Time point:

other: 72 h

Score:

5.67

Reversibility:

not specified

Remarks on result:

other: irritating according to CLP (self classified)

Irritation parameter:

maximum mean total score (MMTS)

Remarks:

:Undiluted test substance

Basis:

mean

Time point:

other: 7 d

Score:

3.33

Reversibility:

not specified

Remarks on result:

other: irritating according to CLP (self classified)

Irritation parameter:

maximum mean total score (MMTS)

Remarks:

:Undiluted test substance

Basis:

mean

Time point:

other: 14 d

Score:

2.33

Reversibility:

not specified

Remarks on result:

other: irritating according to CLP (self classified); except for conjuctival redness, which was the most prominent response and was present in 3/6 animals, the remaining eye irritation response (i.e., chemosis and discharge) were reduced to almost 0 by Day 14.

None

Interpretation of results:

Category II

Remarks:

Migrated information (reversible effects on eye) Criteria used for interpretation of results: EU

Conclusions:

Under the test conditions, the undiluted test substance can be assessed to be a irritating to the eyes. According to CLP criteria (EC 1272/2008) the test substance can be considered to be a category II- eye irritant (with reversible effects on the eye).

Executive summary:

The ocular irritation potential of the test substance, amides, C18 -unsatd., N,N-bis(hydroxyethyl) was investigated using New Zealand white rabbits in accordance with Title 21, Code of Federal Regulations, 191.11.

A volume of 0.1 mL or 0.1 g the test substance was instilled into one eye of each of six New Zealand white rabbits; the other eye served as control. The eyes were evaluated for damage to cornea, iris and bulbar and palpebral conjunctivae at 24, 48, 72 h and 7 and 14 d.

 

Irritation response in the conjuctiva was observed in terms of redness, chemosis and discharge. The mean conjcutival redness score was 2 in 4/6 animals. Further, mean irritation score of 11.33, 7.67, 5.67, 3.33 and 2.33 was observed after 24, 48 and 72 h and 7 and 14 days of observation. Except for conjuctival redness, which was the most prominent response and was present in 3/6 animals, the remaining eye irritation response (i.e., chemosis and discharge) were reduced to almost 0 by Day 14.

Under the test conditions, the undiluted test substance canbe assessed to be a irritating to the eyes. According to CLP criteria (EC 1272/2008), the test substance can be considered to be a category II- eye irritant (with reversible effects on the eye).

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 skin irritation potential of the read across test substance to rabbit skin in accordance with Title 21, Code of Federal Regulations, 191.11. Six animals were treated with undiluted 0.5 mL (0.5 g) of the test substance. The treated areas were covered with a semi-occlusive gauze patch and taped to maintain the test substance in contact with the skin for a duration of 24 h. The degree of erythema and edema were recorded according to Draize scoring system after 24 and 72 h. 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 the abraded and intact rabbit skin. The mean primary skin irritation index (PII) was 5.5. Under the test conditions, the test substance had an irritant effect on the skin and was classified as irritating according to the definitions given in the U.S. Federal Hazardous Substances Act. Further, according to CLP criteria (EC 1272/2008) the test substance may be considered to be Category 2 skin irritant as the mean scores of erythema and edema were >2.3 after 72 h (Casey LM, 1976).

 

Eye irritation

A study was conducted to assess the ocular irritation potential of the read across test substance, amides, C18 -unsatd., N,N-bis(hydroxyethyl) using New Zealand white rabbits in accordance with Title 21, Code of Federal Regulations, 191.11. A volume of 0.1 mL or 0.1 g the test substance was instilled into one eye of each of six New Zealand white rabbits; the other eye served as control. The eyes were evaluated for damage to cornea, iris and bulbar and palpebral conjunctivae at 24, 48, 72 h and 7 and 14 d. Irritation response in the conjuctiva was observed in terms of redness, chemosis and discharge. The mean conjunctival redness score was 2 in 4/6 animals. Further, mean irritation score of 11.33, 7.67, 5.67, 3.33 and 2.33 was observed after 24, 48 and 72 h and 7 and 14 days of observation. Except for conjunctival redness, which was the most prominent response and was present in 3/6 animals, the remaining eye irritation response (i.e., chemosis and discharge) were reduced to almost 0 by Day 14. Under the test conditions, the undiluted test substance can be assessed to be a irritating to the eyes. According to CLP criteria (EC 1272/2008) the test substance can be considered to be a category II- eye irritant (with reversible effects on the eye (Casey LM, 1976).

Another study was conducted to assess the ocular irritation potential of the read across substance amides, C18 -unsatd., N,N-bis(hydroxyethyl) using New Zealand white rabbits in accordance with Title 21, Code of Federal Regulations, 191.11. A volume of 0.1 mL or 0.1 g the 5% diluted test substance in distilled water was instilled into one eye of each of six New Zealand white rabbits; 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. The mean irritation score of 1.0, 0.0 and 0.0 was observed after 24, 48 and 72 h of observation. Under the test conditions, the 5% diluted test substance was assessed to be non-irritating to the eyes and not classified according to CLP criteria (EC 1272/2008 (Casey LM, 1976).

Justification for selection of skin irritation / corrosion endpoint:
Only key study available, conducted on the read across substance amides, C18(unsatd.), N,N-bis(hydroxyethyl); the study was conducted in accordance with Title 21, Code of Federal Regulations, 191.11.

Justification for selection of eye irritation endpoint:
The data showing the most severe effects was chosen as the key study. The study was well conducted on the read across substance amides, C18(unsatd.), N,N-bis(hydroxyethyl) in accordance with Title 21, Code of Federal Regulations, 191.11.

Effects on skin irritation/corrosion: irritating

Effects on eye irritation: irritating

Justification for classification or non-classification

Skin

Based on the available reliable in vivo skin irritation study conducted according to the code of federal regulations, a 24-h, semi-occlusive exposure to the structural analogue amides, C18 -unsatd., N,N-bis(2 -hydroxyethyl) clearly indicates irritation response to skin. Hence, the data derived from the key study justifies R38 classification according to EC criteria (67/548/EEC) and skin irritation category 2; H315-causes skin irritation (hazard statement) according to CLP criteria (EC 1272/2008).

Eye

Based on the available reliable in vivo eye irritation study conducted according to the code of federal regulations, an instillation of the undiluted structurally analogous test substance amides, C18 -unsatd., N,N-bis(hydroxyethyl) into rabbit eyes clearly indicates irritation response. However, instillation of 5% diluted read across test substance into rabbit eyes in another supporting study, did not reveal significant eye irritation response and was assessed to be non-irritating to the eyes. Since the conjuctival redness score observed in the key study with the undiluted test substance, was 2 in 4/6 animals, Category 2; H319 (hazard statement) is warranted according to CLP criteria (EC 1272/2008) classification. On this basis, it is assumed that HE Rape Oil, reaction product with diethanolamine will be irritating to both the skin and the eyes also.