N-C16-18-alkyl-(evennumbered) C18 unsaturated) propane-1,3-diamine

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

disregarded due to major methodological deficiencies

Study period:

3 december 1984 - 10 december 1984

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Study performed according to OECD Guidelines for Testing of Chemicals (1981) 404 but limited report and no data on the identity and purity of the test material.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

not specified

Remarks:

(Only quality assurance statement indicating that at or about the time of the study, "process-based" inspections were made by the Quality Assurance Unit of the critical procedures relevant to this study type.)

Test material

Test material information

Constituent 1

Reference substance name:

N-C16-18-alkyl-(evennumbered, C18 unsaturated) propane-1,3-diamine

EC Number:

629-719-3

Cas Number:

1219010-04-4

Molecular formula:

Unspecified molecule and hence no molecular formula

IUPAC Name:

N-C16-18-alkyl-(evennumbered, C18 unsaturated) propane-1,3-diamine

Details on test material:

- Name of test material (as cited in study report): ARMOGARD C724
- Physical state: brown liquid
- Analytical purity: not stated
- Impurities (identity and concentrations): not stated
- Storage condition of test material: room temperature

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Froxfield Rabbits,Petersfield, Hampshire, UK.
- Age at study initiation: nine to thirteen weeks old
- Weight at study initiation: 2.1 up to 2.8 kg
- Housing: individually in metal cages with perforated floors
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: yes but duration not stated

ENVIRONMENTAL CONDITIONS
- Temperature (°C): approximately 19°C
- Humidity (%): 30-70%
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: One eye remained untreated and served as a control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): undiluted

Observation period (in vivo):

The eyes were examined 1 hour and 1, 2, 3, 4 and 7 days after instillation of the test material.

Number of animals or in vitro replicates:

3 rabbits

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The eyes are not rinsed

SCORING SYSTEM:
Ocular responses were evaluated according to the scheme devised by DRAIZE JH and all (1944) Methods for the study of irritation and toxicity of
substances applied topically to the skin and mucous membranes. J.Pharm.Exp.Ther., 82 p 377 (see below).

TOOL USED TO ASSESS SCORE:
Observation of the eyes was aided by the use of handheld torch.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Remarks:

(mean value of the 24, 48 and 72-hour readings)

Time point:

other: 24,48 and 72 hours

Score:

0

Max. score:

4

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Remarks:

(mean value of the 24, 48 and 72-hour readings)

Time point:

other: 24,48 and 72 hours

Score:

0

Max. score:

4

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Remarks:

(mean value of the 24,48 and 72-hour readings)

Time point:

other: 24,48 and 72 hours

Score:

1.33

Max. score:

4

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

(mean value of the 24, 48 and 72-hour readings)

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

2

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Remarks:

(mean value of the 24, 48 and 72-hour readings)

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

2

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Remarks:

(mean value of the 24, 48 and 72-hour readings)

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

2

Results 7

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #1

Remarks:

(mean value of the 24, 48 and 72-hour readings)

Time point:

other: 24, 48 and 72 hours

Score:

2

Max. score:

3

Results 8

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #2

Remarks:

(mean value of the 24, 48 and 72-hour readings)

Time point:

other: 24, 48 and 72 hours

Score:

1

Max. score:

3

Results 9

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #3

Remarks:

(mean value of the 24, 48 and 72-hour readings)

Time point:

other: 24, 48 and 72 hours

Score:

1

Max. score:

3

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

(mean value of the 24, 48 and 72-hour readings)

Time point:

other: 24, 48 and 72 hours

Score:

1.7

Max. score:

4

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Remarks:

(mean value of the 24, 48 and 72-hour readings)

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Remarks:

(mean value of the 24, 48 and 72-hour readings)

Time point:

other: 24, 48 and 72 hours

Score:

1

Max. score:

4

Irritant / corrosive response data:

A corneal opacity developped in one animal out of three. No iridial inflammation was seen in any of the animals. A diffuse crimson red colouration of the conjunctivae was seen in one animal and was accompanied by considerable swelling with partial eversion of the eyelids. Mild conjunctival
reactions only were seen in one animal.

Any other information on results incl. tables

INDIVIDUAL OCULAR RESPONSES

OCULAR REACTIONS AFTER INSTILLATION OF 0.1 ML

Rabbit n° and sex	Region of eye	One hour	Day after instillation
			1	2	3	4	7
1667 Male	Cornea	0	0	0	0	0	0
	Iris	0	0	0	0	0	0
	Conjunctivae Redness	2	2	2	2	0	0
	Conjunctivae Chemosis	2	1	2	2	0	0
1668 Male	Cornea	0	0	0	0	0	0
	Iris	0	0	0	0	0	0
	Conjunctivae Redness	1	1	1	1	0	0
	Conjunctivae Chemosis	1	0	0	0	0	0
1669 Male	Cornea	0	1	1	2	1	0
	Iris	0	0	0	0	0	0
	Conjunctivae Redness	1	1	1	1	1	0
	Conjunctivae Chemosis	1	1	1	1	0	0

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

No rabbits had a mean score value equal or higher than 2 for corneal opacity. No animals had a mean score value equal or higher than 1 for lesion of the iris. No mean score value for redness of the conjunctivae and chemosis were equal or higher than 2.5 and 2 respectively. According to the
criteria laid down in Council Directive 67/548/EEC (and subsequent adaptations) on the approximation of the laws, regulations and administrative
provisions relating to classification, packaging and labelling of dangerous substances, the test material is not classified Irritant.

Executive summary:

Materials and methods According to OECD 405 (1981), 3 rabbits were instillated in one eye with 0.1 ml of Amine, N-tallow alkyltrimethylenedi-, the other eye acted as a control. Prior to test substance instillation, the eyes of each animal where examined to ensure that there was no pre-existing corneal damage or conjunctival inflammation. Observation and scoring of the ocular reactions were made 1 hour and 1, 2, 3, 4 and 7 days after instillation. Observation was aided by the use of a handheld torch.

Results and discussion A corneal opacity developped in one animal out of three. No iridial inflammation was seen in any of the animals. A diffuse crimson red colouration of the conjunctivae was seen in one animal and was accompanied by considerable swelling with partial eversion of the eyelids. Mild conjunctival reactions only were seen in one animal. No rabbits had a mean score value equal or higher than 2 for corneal opacity. No animals had a mean score value equal or higher than 1 for lesion of the iris. No mean score value for redness of the conjunctivae and chemosis were equal or higher than 2.5 and 2 respectively.

Conclusion Amine, N-tallow alkyltrimethylenedi- was slightly irritating when instillated into the rabbit eye. According to EU criteria, the test material does not require classification for ocular effects.