Isooctadecanoic acid, reaction products with tetraethylenepentamine

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to an internationally approved guideline and followed Good Laboratory Practice standards.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

Deviations to temperature and humidity were slight and did not compromise any aspect of this study.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction products of fatty acids, C14-C18 (branched and linear) and C18 (unsaturated) with tetraethylenepentamine (linear, branched, cyclic)

EC Number:

701-204-9

Cas Number:

68784-17-8

IUPAC Name:

Reaction products of fatty acids, C14-C18 (branched and linear) and C18 (unsaturated) with tetraethylenepentamine (linear, branched, cyclic)

Test material form:

liquid: viscous

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

- Source: Myrtle's Rabbitry Incorporated, Thompson Station, TN
- Housing: wire mesh suspension cage, 1 rabbit/ cage
- Diet (e.g. ad libitum): TEKLAB RABBIT DIET (or otehr comparable diet)
- Water (e.g. ad libitum): ad libitum.
- Acclimation period: at least 7 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-21
- Humidity (%):30-60%
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

IN-LIFE DATES: 17 September, 1993 – 19 October 1993

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1mL

Duration of treatment / exposure:

Test material was instilled into one eye of the test animal while the other eye remained untreated to serve as a control. Nine animal of either sex (Group 1 - six animals; Group 2 - three animals). The eyes of the six rabbit in Group 1 were not rinsed following instillation of the test material. The treated eyes of the three rabbits in Group 2 were rinsed after 30 seconds of test material contact for approximately one minute with approximately 200 mL of lukewarm tap water.

Observation period (in vivo):

The treated eyes of all animals were examined for ocular irritation at 1, 24, 48, 72, and 96 hours and on Days 7 and 14 after treatment. With the exception of the 1 hour scoring, all eyes were scored again for corneal opacity, intensity, and area usig sodium fluorescein. Irritation was graded and scored using the Driaze technique. All eye abnormalities were recorded. Apparent test material residue were adhered to the cornea of two nonrinsed animals in Group 1, animals 1-688 and 2-689. Following the 24 hour reading, an attempt was made to remove the residue using a cotton swab moisterened with saline and/or gentle rinsing of the eyes with saline. A definitive determination could not be made as to whether or not all residue had been removed. This situation was deemed to represent an unrealistic evaluation of the potential to cause eye irritation in humans. Therefore, these animals were considered compromised and subsequently euthanized. The data collected from these animals were not considered for classification and are not presented in this study. Two additonal animals were initiated in the nonrinsed group to serve as replacements for the compromised animals. Each animal was observed daily for any physiological or behavioral abnormalities.
All animals at termination of the experimental phase were euthanized according to laboratory SOPs and discarded.
No statisical analysis was conducted for the evaluation of data.

Number of animals or in vitro replicates:

Nine rabbits

Details on study design:

SCORING SYSTEM: Draize scoring

TOOL USED TO ASSESS SCORE: Sodium fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Remarks on result:

other: nonrinsed

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Remarks on result:

other: nonrinsed

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

1.6

Reversibility:

fully reversible within: 96 h

Remarks on result:

other: nonrinsed

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

2

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: nonrinsed

Results 5

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0.1

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: rinsed

Results 6

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0.2

Reversibility:

fully reversible within: 96 h

Remarks on result:

other: rinsed

Results 7

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

1.9

Reversibility:

fully reversible within: 96 h

Remarks on result:

other: rinsed

Results 8

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

2

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: rinsed

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

Under the conditions of this study, EC701-204-9 is classified as a Category 2 eye irritant in accordance with Regulation (EC) No 1272/2008.

Executive summary:

The primary ocular irritancy of undiluted test material (C1234 -04 -01) was evaluated in compliance with conditions specified in the regulation for the enforcement of the Federal Insecticide, Fungicide, and Rodenticide Act (40 CFR), the Toxic Substances Control Act (40 CFR), and the OECD Guidelines.

The test material produced corneal opacity which had cleared by the Day 14 reading, and conjunctival irritation which had cleared by the Day 14 reading, when applied without rinsing to the eyes of six New Zealand White rabbits. Maximum total irritation scores for individual nonrinsed animals ranged from 12 to 19. the mean total irritation score at the 24 hour reading was 11.7 /110. Positive responses were exhibited by 6/6. No evidence of corrosion was noted. No physiological or behavioral abnormalities were noted.

The test material produced corneal opacity which had cleared by the 72 hour reading, iritis which had cleared by the 96 hour reading, and conjunctival irritation which had cleared by the Day 14 reading, when applied with rinsing to the eyes of three New Zealand White rabbits. Maximum total irritation scores for individual rinsed animals ranged from 14 to 20. The mean total irritation score at the 24 hour reading was 12.7/110. Positive responses were exhibited by 3/3. No evidence of corrosion was noted. No physicological or behavioral abnormalities were noted.

Rinsing appeared to have no significant effect on the severity or persistence of the ocular irritation produced in response to the test material.