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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Remarks:
the tested substance is the amine part of the compound
Adequacy of study:
key study
Study period:
20. Sep 1985 - 11. Oct 1985
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD 405)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Diisopropanolamine- Analytical purity: 99 %- Impurities (identity and concentrations): Monoisopropanolamine < 0.5 %

Test animals / tissue source

Species:
rabbit
Strain:
other: short white russians Chbb-SPF
Details on test animals or tissues and environmental conditions:
TEST ANIMALS- Source: Dr . Karl Thomae GmbH, Biberach, Germany- Weight at study initiation: 2.3 - 2.4 kg- Housing: single cages- Diet (e.g. ad libitum): K4 Alleinfutter für Kaninchen ad libitum (Ssniff Spezialfutter GmbH, 4770 Soest).- Water: tap water ad libitum- Acclimation period: 14 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 20°C ± 1°C- Humidity (%): 60% ± 5%- Air changes (per hr): 15- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL- Amount(s) applied (volume or weight with unit): 100 mg
Duration of treatment / exposure:
72 h
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE- Washing (if done): with warm phyiological saline- Time after start of exposure: 72 hoursSCORING SYSTEM: according to Draize (Appraisals of the Safety of Chemicals in Foods, Drugs and Cosmetics, FDA, Austin 1, Texas 1959, page 51)TOOL USED TO ASSESS SCORE: sodium fluorescein solution, no more data

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24h - 48h - 72h
Score:
1.4
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: fully reversible in all but one animal within 17 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24h - 48h - 72h
Score:
0.4
Max. score:
2
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: fully reversible in all but one animal within 12 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24h - 48h - 72h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: fully reversible in all but one animal within 12 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24h - 48h - 72h
Score:
1.1
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: fully reversible in all but one animal within 10 days
Irritant / corrosive response data:
The test substance caused irreversible effects to the exposed eyes predominantly expressed by heavy erythema, iritis (3/6), opacity and chemosis. Five animals showed bleeding of the mucous membrane. In four animals occured circum-corneal injections after 7 days and in 1 animal circum-corneal injections and eye reactions were not fully reversible within the observation period of 21 days.

Any other information on results incl. tables

Findings: animal 1 - 6:

Animal 1/2/3/4/5/6  1 h  24 h  48 h  72 h  14 days          
A) corneal opacity 1/1/1/1/1/1 1/1/2/1/1/1 1/1/1/1/1/2 1/2/2/2/2/2 0/1/0/2/0/0          
B) area 3/3/3/4/4/3 4/3/2/4/4/4 2/3/2/4/4/4 2/3/2/3/2/3 0/1/0/2/0/0          
a = AxBx5 15/15/15/20/20/15 20/15/20/20/20/20 10/15/10/15/10/30 10/30/30/30/20/30 0/5/0/20/0/0          
                     
Iris 0/0/0/0/0/0 1/0/0/1/1/0 1/0/0/0/1/0 0/1/0/1/1/0 0/0/0/0/1/0          
b = Ax5 0/0/0/0/0/0 5/0/0/5/5/0 5/0/0/0/5/0 0/5/0/5/5/0 0/0/0/0/5/0          
                     
Conjunctiva                    
A) erythema 3/3/3/3/3/3 3/3/3/3/3/3 3/3/3/3/3/3 3/3/3/3/3/3 0/0/0/3/0/0          
B) chemosis 1/2/2/2/2/2 1/2/1/1/1/1 1/1/1/1/1/1 0/1/1/2/1/1 0/0/0/1/0/0          
C) secretion 2/3/3/2/3/3 1/2/2/1/2/2 2/1/2/2/2/2 0/2/2/0/0/1 0/0/0/0/0/0          

c = (A+B+C)x2

12/16/16/14/16/16 10/14/12/12/12/12 12/10/12/12/12/12 6/12/12/10/8/10 0/0/0/8/0/0          

Mean values over 24, 48, and 72 h (OECD score):

Animal 1: Opacity: 1; Iritis: 0.6; Erythema: 3; Chemosis: 0.6

Animal 2: Opacity: 1.3; Iritis: 0.3; Erythema: 3; Chemosis: 1.3

Animal 3: Opacity: 1.7; Iritis: 0; Erythema: 3; Chemosis: 1.7

Animal 4: Opacity: 1.3; Iritis: 0.6; Erythema: 3; Chemosis: 1.3

Animal 5: Opacity: 1.3; Iritis: 1; Erythema: 3; Chemosis: 1.3

Animal 6: Opacity: 1.7; Iritis: 0; Erythema: 3; Chemosis: 1.7

The test substance caused irreversible effects to the exposed eyes predominantly expressed by heavy erythema, iritis (3/6), opacity and chemosis. Five animals showed bleeding of the mucous membrane. In four animals occured circum-corneal injections after 7 days and in 1 animal circum-corneal injections and eye reactions were not fully reversible within the observation period of 21 days.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria