Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
05 Jun 1991 - 08 Jun 1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions. Only 72 h observation period, analytical purity of test substance not clearly specified.
Justification for type of information:
The Glycol ester category covers esters of an aliphatic diol (ethylene glycol (EG), propylene glycol (PG) or 1,3-butyleneglycol (1,3-BG)) and one or two carboxylic fatty acid chains. The fatty acid chains comprise carbon chain lengths ranging from C6 to C18, mainly saturated but also mono unsaturated C16 and C18, branched C18 and epoxidized C18.
 
The available data allows for an accurate hazard and risk assessment of the category and the category concept is applied for the assessment of environmental fate and environmental and human health hazards. Thus, where applicable, environmental and human health effects are predicted from adequate and reliable data for source substance(s) within the group by interpolation to the target substances in the group (read-across approach) applying the group concept in accordance with Annex XI, Item 1.5, of Regulation (EC) No 1907/2006. In particular, for each specific endpoint the source substance(s) structurally closest to the target substance is/are chosen for read-across, with due regard to the requirements of adequacy and reliability of the available data. Structural similarities and similarities in properties and/or activities of the source and target substance are the basis of read-across.
A detailed justification for the grouping of chemicals and read-across is provided in the technical dossier (see IUCLID Section 13).
Cross-reference
Reason / purpose:
read-across source

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
analytical purity of test substance not clearly specified; observation period terminated at 72 h, although not fully reversible at that point
Qualifier:
according to
Guideline:
other: FHSA/CPSC: Federal Hazardous Substances Control Act, 16 CFR 1500.42
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Davidson's Mill Farm, S. Brunswick, NJ, USA
- Housing: individually in suspended stainless steel caging with mesh floors.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 34 or 51 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5 - 21.5

Test system

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



Duration of treatment / exposure:
72 h
Observation period (in vivo):
72 h
Reading time points: 24, 48 and 72 h
Number of animals or in vitro replicates:
3 males and 3 females
Details on study design:
SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
other: reversibility: not applicable
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
48 h
Score:
0
Max. score:
0
Reversibility:
other: reversibility: not applicable
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
72 h
Score:
0
Max. score:
0
Reversibility:
other: reversibility: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
other: reversibility: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
48 h
Score:
0
Max. score:
0
Reversibility:
other: reversibility: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
72 h
Score:
0
Max. score:
0
Reversibility:
other: reversibility: not applicable
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
24 h
Score:
0.17
Max. score:
1
Reversibility:
other: reversibility: not applicable
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
48 h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
72 h
Score:
0
Max. score:
0
Reversibility:
other: reversibility: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
24 h
Score:
1.33
Max. score:
2
Reversibility:
other: reversibility: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
48 h
Score:
0.67
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 72 h
Irritant / corrosive response data:
The test substance has slight irritaing effects when instilled into rabbit eyes. At the end of the observation period slight hyperemia in 2 animals was left.
Other effects:
All animals appeared active and healthy. Apart from the eye irritation noted in Table 1, there were no signs of systemic toxicity, adverse pharmacologic effects or abnormal behavior.

Any other information on results incl. tables

Table1: Individual eye irritation scores

 

Average irritation score of 24, 48 and 72 h

Animal number

Cornea

Iris

Conjunctiva

Chemosis

8797

0

0

1

0.33

8798

0

0

0.66

0

8799

0

0

1.33

0

8800

0

0

0.33

0

8801

0

0

1

0

8802

0

0

0.33

0

Mean

0

0

0.775

0.055

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified