Amines, C20-22-alkyldimethyl

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

01/1996-06/1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: According to the OECD Guideline and it is GLP

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)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Amines, C12-16-alkyldimethyl

EC Number:

270-414-6

EC Name:

Amines, C12-16-alkyldimethyl

Cas Number:

68439-70-3

IUPAC Name:

N,N-dimethylhexadecan-1-amine

Constituent 2

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

Details on test material:

- Physical state: a clear, colourless liquid
- Storage condition of test material: at ambient temperature, in the original container

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Age at study initiation: 5 months old
- Weight at study initiation: 2.43 kg

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

single 0.1 mL exposure

Duration of treatment / exposure:

Ocular reactions were assessed 1, 24, 48 and 72 hours after treatment and Days 8, 15 and 22.

Observation period (in vivo):

the behavior of the rabbit was observed for several minutes immediately following installation of the test material.

Number of animals or in vitro replicates:

one rabbit

Details on study design:

SCORING SYSTEM:
Cornea
Area of cornea affected by lesion
No lesion: 0
One-quarter or less, but not zero: 1
Greater than one-quarter, less than one-half: 2
Greater then one-half, less than three-quarters: 3
Greater than three-quarters, up to whole area: 4

Conjunctivae
No discharge:0
any amount different from normal (does not include small amounts observed in inner canthus of normal animals): 1
Discharge with moistening of the lids and hairs just adjacent to the lids: 2
Discharge with moistening of the lids and hairs and affecting a considerable area around the eye:3
Extensive mucoid disharge:4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 1 h

Score:

0

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 24 and 48 h

Score:

1

Results 3

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 1, 24, 48 and 72 hours

Score:

1

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 1 hour

Score:

2

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 24 h

Score:

3

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 48 h

Score:

2

Any other information on results incl. tables

Animal No. And sex: 32TD937F		Pain evaluation response: 0
Region of the eye	Response	Grade of response at time after instillation
		Hours				Days
		1	24	48	72	8	15	22
Cornea	Opacity	0	1F+	1F+	0F-	0F-	0	0
	Area	0	2	1	0	0	0	0
	Ulceration	-	-	-	-	-	-	-
	Stippling	-	-	-	-	-	-	-
Iris	Value	1	1	1	1	1	0	0
Conjunctiva	Redness	2	3	2	*	*	*	1
	Chemosis	2	3	1A	2A	0A	0A	0A
	Discharge	3	3	3	2	2	2	0
	Necrosis	-	-	-	*	*	*	*
	Ulceration	-	-	-	*	*	*	*
				B	B	B	BC	CD
								E

*: impossible to assess due to swelling

F+: Fluorescein positive

F-: Fluorescein negative

A: Blepharitis

B: Eye held closed

C: Peri-orbital exfoliation

D: Peri-orbital hair loss

E: Peri-orbital sloughing

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this test and the criteria of the EEC, the substance was classified as having the "risk of serious damage to eyes".

Executive summary:

According to the OECD Guideline 405. The potencial of the substance to cause damage to the conjunctivae, iris or cornea was assessed in the New Zealand White rabbit, subjected to a single ocular instillation of 0.1mL of the test material. Ocular reactions were assessed 1, 24, 48 and 72 hours after treatment and on Day 8, 15 and 22.

Instillation of the test material caused no initial pain response.

Under the conditions of this test and the criteria of the EEC, the substance was classified as having the "risk of serious damage to eyes"

In the light of the severe response observed in this sentinel rabbit, no further animals were committed to this study.