Registration Dossier

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2 Feb to 9 Feb 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD guideline study, to GLP, with slight deviations which are not expected to affect the outcome

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
temperature slightly outside of recommended range. Sequential testing strategy preferred.
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
temperature slightly outside of recommended range. Sequential testing strategy preferred.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1-(N,N-bis(2-hydroxyethyl)amino)propan-2-ol
EC Number:
229-764-5
EC Name:
1-(N,N-bis(2-hydroxyethyl)amino)propan-2-ol
Cas Number:
6712-98-7
Molecular formula:
C7H17NO3
IUPAC Name:
1-[bis(2-hydroxyethyl)amino]propan-2-ol
Test material form:
other: Clear liquid
Details on test material:
- Name of test material (as cited in study report): Diethanolisopropanolamine (DEIPA)
- Substance type: Technical product
- Physical state: Liquid
- Analytical purity: 93%
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: No data
- Isomers composition: No data
- Purity test date: Not specified
- Lot/batch No.: 980035B
- Expiration date of the lot/batch: Not specified
- Stability under test conditions: Not specified
- Storage condition of test material: Not specified

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Covance Research Products, Inc (Kalamazoo)
- Age at study initiation: 8 weeks
- Weight at study initiation: 2.9-3 kg
- Housing: Not specified
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least 2 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 +/- 3 [OECD guideline recommends 20 +/- 3, but unlikely to affect the outcome]
- Humidity (%): 40-60
- Air changes (per hr): 12-15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye served as a control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml

VEHICLE
Not applicable
Duration of treatment / exposure:
Eyes held closed for approximately 1 second after instillation
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3 [OECD guideline recommends a sequential testing strategy, in which an initial test is performed on one animal, using two additional animals if there are no severe irritant or corrosive effects exhibited. It is not clear from the test report if this sequential strategy was used, or if all three animals were treated concurrently]
Details on study design:
REMOVAL OF TEST SUBSTANCE
Eyes were unwashed after treatment

SCORING SYSTEM: Scored for corneal opacity (0-4), conjuctival redness (0-3), chemosis (0-4), dischage (0-3) and iris reddening (0-2)

TOOL USED TO ASSESS SCORE: Binocular loupe and white halogen light

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Remarks:
discharge
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Remarks:
discharge
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: Reversibility not applicable since no effects seen
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
discharge
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: Reversibility not applicable since no effects seen
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Reversibility not applicable since no effects seen
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Reversibility not applicable since no effects seen
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Remarks:
reddening
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
iris score
Remarks:
reddening
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: Reversibility not applicable since no effects seen
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Remarks:
reddening
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: Reversibility not applicable since no effects seen
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Slight to moderate irritation was seen in the eyes of all three rabbits, which had fully reversed within 7 days.
All rabbits had moderate conjunctival redness, slight or moderate chemosis and moderate ocular discharge 1 hour after instillation. Twenty-four hours after instillation all rabbits had slight or moderate conjunctival redness and slight chemosis, in addition one rabbit exhibited moderate ocular discharge, corneal opacity and iris reddening. All rabbits had slight conjunctival redness at 48 and 72 hours after instillation. The test was terminated on day 8 due to the eyes of all rabbits having returned to normal.
Other effects:
No signifcant effects on body weight

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In a GLP study, conducted according to OECD guideline 405, the instillation of undiluted DEIPA (0.1 ml) into the right eye of 3 rabbits was considered to cause slight to moderate transient eye irritation.
Executive summary:

In a GLP study, conducted according to OECD guideline 405, an aliquot of 0.1 ml of undiluted DEIPA was instilled into the conjunctival sac of the right eye of three New Zealand White rabbits. The contralateral eye served as the untreated control. An ocular anaesthetic was used for 2 rabbits following discomfort observed in the second rabbit dosed. The eyes were examined for conjunctival redness, discharge, chemosis, corneal opacity and iris reddening at approximately 1, 24, 48 and 72 hours, and 7 days, post-instillation.

 

All rabbits had moderate conjunctival redness, slight or moderate chemosis and moderate ocular discharge 1 hour after instillation. Twenty-four hours after instillation all rabbits had slight or moderate conjunctival redness and slight chemosis, in addition one rabbit exhibited moderate ocular discharge, corneal opacity and iris reddening. All rabbits had slight conjunctival redness at 48 and 72 hours after instillation. The test was terminated on day 8 due to the eyes of all rabbits having returned to normal.

 

In this reliable study, the instillation of neat DEIPA was considered to cause slight to moderate transient eye irritation in rabbits.

Categories Display