Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
10.03.2006 to 29.05.2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD & EEC guideline study no deviations GLP
Cross-reference
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
470-680-5
EC Name:
-
Cas Number:
958872-63-4
Molecular formula:
C16H30O3
IUPAC Name:
1-[2-({1,7,7-trimethylbicyclo[2.2.1]heptan-2-yl}oxy)propoxy]propan-2-ol; 1-{[1-({1,7,7-trimethylbicyclo[2.2.1]heptan-2-yl}oxy)propan-2-yl]oxy}propan-2-ol; 2-[2-({1,7,7-trimethylbicyclo[2.2.1]heptan-2-yl}oxy)propoxy]propan-1-ol; 2-{[1-({1,7,7-trimethylbicyclo[2.2.1]heptan-2-yl}oxy)propan-2-yl]oxy}propan-1-ol
Details on test material:

- Name of test material (as cited in study report): Dipropylenglykolisobornylether (isomerengemisch)
- Substance type: mixture of isomers
- Physical state: liquid
- Analytical purity: 97.9% (a/a)
- Impurities (identity and concentrations): as submited substance
- Composition of test material, percentage of components: as submited substance
- Isomers composition: as submited substance
- Lot/batch No.: V04/010-13N
- Expiration date of the lot/batch: 01.03.2008
- Storage condition of test material: ambient temperature
- Other: certificate of analysis Nº AZ-212, Clariant GmbH, Analytical services (23.03.2005)

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Rabbit, New Zealand White / specific Pathogen Free (SPF) strain were supplied by Charles River Laboratories Site ESD-Romans-01400 Châtillon sur Chalaronne, France.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.1 ml of test item / eye
- Concentration (if solution):undiluted


Duration of treatment / exposure:
test item absorbed / not removed after dosage
Observation period (in vivo):
1, 24, 48, 72 hours and 7 days after dosing
Number of animals or in vitro replicates:
3 females
Details on study design:
Undiluted test item was introduced into the right eye of each animal by gently pulling away the lower lid from the eyeball to form a cup into which the test item was placed. The lids were then held shut for a few seconds to prevent loss of the test item. No rinse of the eye was performed. The left eye remained untreated.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
, conjunctival redness
Basis:
animal #1
Remarks:
no.343
Time point:
other: 24, 48, 72 h
Score:
1.3
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: mean, observed values
Irritation parameter:
conjunctivae score
Remarks:
, conjunctival redness
Basis:
animal #2
Remarks:
no.345
Time point:
other: 24, 48, 72 h
Score:
1.3
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: mean, observed values
Irritation parameter:
conjunctivae score
Remarks:
, conjunctival redness
Basis:
animal #3
Remarks:
no.347
Time point:
other: 24, 48, 72 h
Score:
1.3
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: mean, observed values
Irritation parameter:
chemosis score
Remarks:
, conjunctival chemosis
Basis:
animal #1
Remarks:
no.343
Time point:
other: 24, 48, 72 h
Score:
1.3
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: mean, observed values
Irritation parameter:
chemosis score
Remarks:
, conjunctival chemosis
Basis:
animal #2
Remarks:
no.345
Time point:
other: 24, 48, 72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: mean, observed values
Irritation parameter:
chemosis score
Remarks:
, conjunctival chemosis
Basis:
animal #3
Remarks:
no.347
Time point:
other: 24, 48, 72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: mean, observed values
Irritation parameter:
cornea opacity score
Remarks:
, corneal opacity
Basis:
animal #1
Remarks:
no.343
Time point:
other: 24, 48, 72 h
Score:
1.7
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Remarks:
, corneal opacity
Basis:
animal #2
Remarks:
no.345
Time point:
other: 24, 48, 72 h
Score:
1.7
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Remarks:
, corneal opacity
Basis:
animal #3
Remarks:
no.347
Time point:
other: 24, 48, 72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
iris score
Remarks:
, iris inflammation
Basis:
animal #1
Remarks:
no.343
Time point:
other: 24, 48 h
Score:
0.7
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: mean, observed values
Irritation parameter:
iris score
Remarks:
, iris inflammation
Basis:
animal #2
Remarks:
no.345
Time point:
other: 24, 48 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: mean, observed values
Irritation parameter:
iris score
Remarks:
, iris inflammation
Basis:
animal #3
Remarks:
no.347
Time point:
other: 24, 48 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: mean, observed values
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 7 days
Other effects:
None:
There was no indication of a systemic effect of treatment.
The body weights of animals were considered to be within the normal range of variability.

Any other information on results incl. tables

None: There was no indication of a systemic effect of treatment. The body weights of animals were considered to be within the normal range of variability.

Applicant's summary and conclusion

Interpretation of results:
other: the substance is not irritating according to Directive 67/548/EEC but it is classified as Eye irritant Category 2 according to CLP Regulation.
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
These results indicate that based upon classification criteria of European Directives concerning the classification, packaging and labelling of dangerous substances (67/548/EEC and subsequent revisions) Dipropylen glycol isobornyl ether (mixture of isomers) is not irritating to eyes.

According to the CLP Regulation, the substance is classified as Eye irritant, Category 2, based on the scores obtained for the corneal opacity, which are above 1 for the three animals.
Executive summary:

The acute eye irritation of Dipropylenglykolisobornylether (isomerengemisch) was investigated in rabbits in accordance with OECD Guideline 405 (Acute Eye Irritation / Corrosion) and EU Guidelines B.5.

A 0.1 ml aliquot of the test item (undiluted) was introduced in to the right eye of a total of 3 animals.

The resulting reaction to treatment was assessed 1, 24, 48,and 72 hours and 7 days after treatment.

Slight conjunctival redness, chemosis an ocular discharges were observed in the three animals at 1 hour examination.

Moderate concjuntival redness and ocular discharges, well defined chemosis, slight to moderate iris inflammation and moderate corneal opacity were then observed in the three animals at 24 hours examination.

Slight to absent ocular discharge, slihgt concjuntival redness, well defined to absent chemosis, slight to moderate to absent iris inflammation and slight cornela opacity were observed in 1 animal at the 48 and 72 hours examinations.

Observations of the remaining 2 animals, performed at the same examination time, revealed slight concjuntival redness and slight to absent chemosis.

Slight to well defined corneal opacity was observed in these two animals at 48 hours examination while slight corneal opacity was observed in the same animals at 72 hours examination.

Complete recovery has ocurred 7 days after dosing. There was no indication of systemic effect of treatment. The body weights of animals were considered to be within the normal range of variability.

These results indicate that based upon classification criteria of European Directives concerning the classification, packaging and labelling of dangerous substances (67/548/EEC and subsequent revisions) Dipropylen glycol isobornyl ether (mixture of isomers) is not irritating to eyes.

According to the CLP Regulation, the substance is classified as Eye irritant, Category 2, based on the scores obtained for the corneal opacity (calculated as the mean scores following grading at 24, 48 and 72 h) which are above 1 for the three animals and which fully reverses within the observation period.