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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
02 Jun - 22 Jul 2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report date:
2011

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted in 2002
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
adopted in 2008
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Groupe interministeriel des produits chimiques, Ivry sur Seine, France

Test material

Constituent 1
Chemical structure
Reference substance name:
(2R,3R,4S,5S,6R)-2-(heptyloxy)-6-(hydroxymethyl)oxane-3,4,5-triol; (2R,3R,4S,5S,6R)-2-{[(2R,3S,4S,5R,6R)-6-(heptyloxy)-3,4,5-trihydroxyoxan-2-yl]methoxy}-6-(hydroxymethyl)oxane-3,4,5-triol; (2R,3R,4S,5S,6R)-2-{[(2R,3S,4S,5R,6R)-6-{[(2R,3S,4S,5R,6R)-6-(heptyloxy)-3,4,5-trihydroxyoxan-2-yl]methoxy}-3,4,5-trihydroxyoxan-2-yl]methoxy}-6-(hydroxymethyl)oxane-3,4,5-triol
EC Number:
807-654-3
Cas Number:
1627851-18-6
Molecular formula:
(C6H10O5)nC7H16O, n - number of D-glucopyranose units
IUPAC Name:
(2R,3R,4S,5S,6R)-2-(heptyloxy)-6-(hydroxymethyl)oxane-3,4,5-triol; (2R,3R,4S,5S,6R)-2-{[(2R,3S,4S,5R,6R)-6-(heptyloxy)-3,4,5-trihydroxyoxan-2-yl]methoxy}-6-(hydroxymethyl)oxane-3,4,5-triol; (2R,3R,4S,5S,6R)-2-{[(2R,3S,4S,5R,6R)-6-{[(2R,3S,4S,5R,6R)-6-(heptyloxy)-3,4,5-trihydroxyoxan-2-yl]methoxy}-3,4,5-trihydroxyoxan-2-yl]methoxy}-6-(hydroxymethyl)oxane-3,4,5-triol
Test material form:
other: solid, not further specified
Details on test material:
- Name of test material (as cited in study report): heptylglucoside
- Physical state: brown solid
- Analytical Purity: > 99%
- Lot/batch No.: 3675JG
- Storage condition of test material: room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hypharm, Roussay, France
- Age at study initiation: 11 or 12 weeks
- Weight at study initiation: 1.90-2.28 kg
- Housing: individually in conventional air conditioned animal husbanding
- Diet: tap water, ad libitum
- Water: foodstuff (Safe-112), ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): at least ten
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 02 Jun 2014 To: 30 Jun 2014

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: 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:
single application without washing
Observation period (in vivo):
Up to 21 days
Reading time points: 1, 24, 48 and 72 h and 7, 14 and 21 days
Number of animals or in vitro replicates:
3 females
Details on study design:
SCORING SYSTEM: Draize score system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
probability of moderate irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
probability of moderate irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 2
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Remarks on result:
probability of moderate irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 2
Max. score:
2
Reversibility:
fully reversible within: 7 days
Remarks on result:
probability of moderate irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Remarks on result:
probability of moderate irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
probability of moderate irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 2
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
probability of moderate irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 2
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
probability of moderate irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 2
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
probability of moderate irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 1.7
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
probability of moderate irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
probability of moderate irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 1.7
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
probability of moderate irritation
Irritant / corrosive response data:
During the study the following moderate to important and partially reversible ocular lesions have been observed:
-conjunctivae: a moderate redness, noticed 24 h after the test substance instillation and totally reversible by Day 7, associated with slight to important chemosis, noted 24 h after the test item instillation and totally reversible by Day 7.
-iris: a congestion or haemorrage, noted 1 h or 24 h after the test item instillation and totally reversible between Days 7 and 14.
-cornea: a moderate corneal opacity, detected 24 h after the test substance instillation and totally reversible by Day 7 in two animals but persisting until the last day of the test (Day 21) with same intensity (grade 2) in the last animal.
Finally, a corneal neovascularization was noted on Day 14 and Day 21 in the same animal. In addition, a corneal oedema was observed in that animal on Day 7.

Any other information on results incl. tables

Table 1 Individual and mean scores of conjuctivae, iris and cornea

Animal N.

Time after treatment

Conjuctivae

Iris

Cornea

 

Chemosis

Redness

Lesion

Opacity

1

24 h

3

2

2

2

48 h

1

2

2

2

72 h

1

2

2

2

 

Mean

1.7

2

2

2

2

24 h

1

2

1

2

48 h

1

2

1

2

72 h

1

2

1

2

 

Mean

1

2

1

2

3

24 h

2

2

2

2

48 h

1

2

2

2

72 h

2

2

2

2

 

Mean

1.7

2

2

2

 

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: Eye Dam. 1, H318
DSD: Xi, R41