Amines, tri-C8-10-alkyl

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: OECD guideline study, with acceptable restrictions (no data on test substance purity)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

(adopted 1981)

Deviations:

yes

Remarks:

(test design not in accordance with sequential testing strategy, no systemic or ocular anesthetic used as laid down in the Supplement of the recent version of the OECD TG 405 (2012))

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Trioctylamine

EC Number:

214-242-1

EC Name:

Trioctylamine

Cas Number:

1116-76-3

Molecular formula:

C24H51N

IUPAC Name:

N,N-dioctyloctan-1-amine

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): Tri-N-Octylamine
- Analytical purity: no data
- Impurities (identity and concentrations): no data

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Savo, Med. Versuchstierzuchten GmbH, D-7964 Kissleg, Germany
- Age at study initiation: no data
- Weight at study initiation: mean: 2.91 kg
- Housing: single
- Diet (ad libitum): Kliba 341, 4 mm; Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland (about 130 g per animal per day)
- Water (ad libitum): tap water (about 250 mL per animal per day)
- Acclimation period: at least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: Untreated eyes of the same animals

Amount / concentration applied:

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

Duration of treatment / exposure:

Single application to the conjunctival sac of the right eye lid; the substance was not washed out

Observation period (in vivo):

8 d
(The study was discontinued after 8 days, since all eye reactions had subsided.)

Number of animals or in vitro replicates:

3 male rabbits

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: no data

READINGS:
Readings of eye reactions were performed 1 h, 24 h, 48 h, 72 h, and 8 days after application.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

(of 3 animals)

Time point:

other: 24-48-72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

(of 3 animals)

Time point:

other: 24-48-72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 24-48-72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 8 days

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 24-48-72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 8 days

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: 24-48-72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 8 days

Results 6

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

(of 3 animals)

Time point:

other: 24-48-72 h

Score:

0

Max. score:

3

Reversibility:

other: not applicable

Any other information on results incl. tables

Results:

 

Time	Rabbit no.	Cornea		Iris	Conjunctivae			Additional findings
		Opacity	Area		Redness	Chemosis	Discharge
1 h	1	0	0	0	2	0	1	-
	2	0	0	0	2	0	1	-
	3	0	0	0	2	0	1	-
24 h	1	0	0	0	1	0	0	-
	2	0	0	0	2	0	0	-
	3	0	0	0	2	0	0	-
48 h	1	0	0	0	1	0	0	-
	2	0	0	0	2	0	0	-
	3	0	0	0	2	0	0	-
72 h	1	0	0	0	1	0	0	-
	2	0	0	0	2	0	0	-
	3	0	0	0	2	0	1	-
8 d	1	0	0	0	0	0	0	Loss of hair at margins of eyelids
	2	0	0	0	0	0	0	Loss of hair at margins of eyelids
	3	0	0	0	0	0	0	Loss of hair at margins of eyelids
mean (24-48-72 h)	1	0	0	0	1.0	0	-	-
	2	0	0	0	2.0	0	-	-
	3	0	0	0	2.0	0	-	-

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU