Rape oil, reaction products with diethanolamine

Eye irritation

Administrative data

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.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

N,N-bis(2-hydroxyethyl)oleamide

EC Number:

202-281-7

EC Name:

N,N-bis(2-hydroxyethyl)oleamide

Cas Number:

93-83-4

Molecular formula:

C22H43NO3

IUPAC Name:

N,N-bis(2-hydroxyethyl)octadec-9-enamide

Constituent 2

Reference substance name:

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

IUPAC Name:

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

Details on test material:

- Name of test material (as cited in study report): Varamide A-7

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

None

Test system

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.

Results and discussion

In vivo

Results

Results 1

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)

Results 2

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)

Results 3

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)

Results 4

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)

Results 5

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.

Any other information on results incl. tables

None

Applicant's summary and conclusion

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).