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Toxicological information

Eye irritation

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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

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
Chemical structure
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

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 1 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24 and 48 h
Score:
1
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 1, 24, 48 and 72 hours
Score:
1
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 1 hour
Score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24 h
Score:
3
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.

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