Dimethyl(tetradecyl)amine

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

01/1996-02/1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: There are not deviations from the recommended guideline.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Hexadecyldimethylamine

EC Number:

203-997-2

EC Name:

Hexadecyldimethylamine

Cas Number:

112-69-6

Molecular formula:

C18H39N

IUPAC Name:

N,N-dimethylhexadecan-1-amine

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Froxfield SPF Rabbits, Broadway Farm, Froxfield, Hampshire, England
- Weight at study initiation: 2.94 and 2.95 kg
- Housing: individually in suspended stainless steel cages
- Diet (e.g. ad libitum): free access
- Water (e.g. ad libitum): free access


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 (15-23)
- Humidity (%): 55 (40-70)
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

4 hours

Observation period (in vivo):

1, 24, 48 and 72 hours and on day 8, 15 and 22.

Number of animals or in vitro replicates:

three animals

Details on study design:

Scoring system:
Iris Grade
Normal 0
Markedly deepened folds, congestion swelling, moderate circumcorneal injection 1
No reaction to light, haemorrhage, gross destrution 2

Conjunctivae
Redness Grade
Vessels normal 0
Some vessels definitely injected 1
Diffuse, crimson-red, individual vessels not easily discernible 2
Diffuse beefy-red 3

Chemosis Grade
No swelling 0
Any swelling above normal 1
Obvious swelling with partial eversion of lids 2
Swelling with lids about than half-closed 3
Swelling with lids more than half-closed 4

Cornea
Area of cornea affeced by lesion Grade
No lesion 0
One-quarter or less, but not zero 1
Greater than one-quarter, less than one-half 2
Greater than one-quarter, less than three-half 3
Greater than three-quarter, up to whole area 4

Conjunctivae
Discharge Grade

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

4

Remarks on result:

other: no effects observed

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0.67

Max. score:

2

Reversibility:

not fully reversible within: 22 days

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48 and 72 h

Score:

1

Max. score:

3

Reversibility:

not fully reversible within: 22 days

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48 and 72 h

Score:

1.23

Max. score:

4

Reversibility:

not fully reversible within: 22 days

Irritant / corrosive response data:

Iritis and slight conjunctivitis were seen in all animals one hour after instillation. Slight conjunctivitis was seen up to 72 hours following instillation; iritis was observed in two animals during this time. Very slight conjunctivitis was observed in all rabbits during the remainder of the observation period; two animals also showed iritis, which resolved by Day 15 in one but persisting to termination in the other. Blepharitis was seen in two animals from Day 2 and in the other from Day 4; this was accompanied in the latter part of the observation period by peri-orbital hair loss and/or exfoliation and sloughing.
Instillation of the test material caused no initial pain response.

Any other information on results incl. tables

Mean valuea for occulat lesions 24, 48 and 72 h after instillation

Animal number and sex	Corneal opacity	Iridial lesions	Redness of Conjunctiva	Chemosis
27TK490F	0	1	1	2
27TK533F	0	1	1	0,7
27TK534F	0	0	1	1

Grades for occular irritation responses

Animal No. and Sex: 27TK490F#		Pain evaluation response: 0
Region of the eye	Response		Grade of response at time alter instillation Hours              Days
		1	24	48	72	8	15	22
Comea	Opacity	0	0	0	0	0	0	0
	Area	0	0	0	0	0	0	0
	Ulceration
	Stippling
Iris	Value	1	1	1	1	0	0	1
Conjunctiva	Redness	2	1	1	1	*	*	1
	Chemosis	0	2	2	2A	OA	OA	0
	Discharge	2	1	1	2	*	*	1
	Necrosis	-
	Ulceration	-	-
							BC	BC

 

Grades for occular irritation responses

Animal No. and Sex: 27TK534F		Pain evaluation response: 0
Region of the eye	Response		Grade of response at time alter instillation Hours           Days
		1	24	48	72	8	15	22
Cornea	Opacity	0	0	0	0	0	0	0
	Area	0	0	0	0	0	0	0
	Ulceration
	Stippling							-
Iris	Value	1	0	0	0	0	0	0
Conjunctiva	Redness	1	1	1	1	1	1	1
	Chemosis	I	2A	IA	OA	OA	OA	0
	Discharge	1	1	0	0	1	0	0
	Necrosis
	Ulceration
							BC	BC

#Sentinel animal

* Impossible to open eye sufficiently to assess

A Blepharitis

B Peri-orbital exfoliation

C Peri-orbital hair loss

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this test the test substance produced effects which were not fully reversible within 22 days.

Executive summary:

The objective of this Acute Eye Irritation Test was to assess the potential of the test material to cause damage to the conjunctivae, cornea or iris after a single 0.1 mL exposure of indeterminate duration. The behaviour of the rabbits was observed for several minutes immediately following installation of the test material. The untreated eye was used as a comparision with the treated eye during assessment ocular lesions.

Iritis and slight conjunctivitis were seen in all animals one hour after instillation. Slight conjunctivitis was seen up to 72 hours following instillation; iritis was observed in two animals during this time. Very slight conjunctivitis was observed in all rabbits during the remainder of the observation period; two animals also showed iritis, which resolved by Day 15 in one but persisting to termination in the other. Blepharitis was seen in two animals from Day 2 and in the other from Day 4; this was accompanied in the latter part of the observation period by peri-orbital hair loss and/or exfoliation and sloughing. Instillation of the test material caused no initial pain response.

Under the conditions of this test the test substance produced irreversible eye lesions.