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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2006-03-01 to 2006-03-09
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in compliance with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive and done to a valid guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethyl (3aR,7R,7aR)-2,2-dimethyl-7-[(methylsulfonyl)oxy]-3a,6,7,7a-tetrahydro-1,3-benzodioxole-5-carboxylate
EC Number:
606-548-2
Cas Number:
204254-84-2
Molecular formula:
C13 H20 O7 S
IUPAC Name:
Ethyl (3aR,7R,7aR)-2,2-dimethyl-7-[(methylsulfonyl)oxy]-3a,6,7,7a-tetrahydro-1,3-benzodioxole-5-carboxylate
Test material form:
other: solid
Details on test material:
White to beige solid
Purity 99.2%
Expiry date: 21 December 2006

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Age at treatment : 12-13 weeks
Standard Laboratory Conditions
Air-conditioned with ranges for room temperature 17-23 °C, relative humidity 30-70 % and approximately 10-15 air changes per hour. Room temperature and humidity were monitored continuously and values outside of these ranges may have occasionally occurred, usually following room
cleaning. These transient variations are considered not to have any influence on the study and, therefore, these data are not reported but are retained at RCC. The animals were provided with an automatically controlled light cycle of 12 hours light and 12 hours dark. Music was played during
the daytime light period.
Accommodation: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls. Wood blocks (RCC Ltd,
Füllinsdorf) and haysticks 4642 (batch no. 35/05 and 77/05, Provimi Kliba AG) were provided for gnawing.
Standard pelleted rabbit maintenance diet and community tap water were provided.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The right eye of each animal served as control
Amount / concentration applied:
0.1 g per animal. It was not recorded whether the test material was ground to a fine dust as the current guideline recommends.
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
1, 24, 48 and 72 hours after administration
Number of animals or in vitro replicates:
3 (one male, two female)
Details on study design:
On the day of treatment, 0.1 g of the test item was placed in the conjunctival sac of the left eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of test item. The right eye remained untreated and served as the reference control. The treated eyes were not rinsed after instillation.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72
Score:
0.11
Max. score:
13
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
The mean score was calculated across 3 scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately. The individual mean scores for corneal opacity and iris were 0.00 for all three animals. The individual mean scores for the conjunctivae were 0.33, 0.00 and 0.00 for reddening, respectively, and 0.00 for chemosis for all three animals.

Any other information on results incl. tables

Eye Irritation Scores - Individual values:

 Animal No. & Sex  Evaluation Interval  Corneal Opacity  Area of Corneal Opacity  Iris  Conjunctivae Redness  Conjunctivae Chemosis  Cumulative Score  Cumulative mean  Sclera
 91M  1 Hour  0  0  0  1  0  1.00    1
 92F  1 Hour  0  0  0  1  0  1.00  1.00  0
 93F  1 Hour  0  0  0  1  0  1.00    1
 91M  24 Hours  0  0  0  1  0  1.00    0
 92F  24 Hours  0  0  0  0  0  0.00  0.33  0
 93F  24 Hours  0  0  0  0  0  0.00    0
 91M  48 Hours  0  0  0  0  0  0.00    0
 92F  48 Hours  0  0  0  0  0  0.00  0.00  0
 93F  48 Hours  0  0  0  0  0  0.00    0
 91M  72 Hours  0  0  0  0  0  0.00    0
 92F  72 Hours  0  0  0  0  0  0.00  0.00  0
 93F  72 Hours  0  0  0  0  0  0.00    0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
The single instillation of the test item into the conjunctival sac caused mild, early-onset and transient ocular changes, such as slight reddening of the conjunctivae and sclerae as well as slight ocular discharge. These effects were reversible and were no longer evident 24 or 48 hours after treatment. No abnormal findings were observed in the cornea or iris of any animal at any of the examinations.
No staining of the cornea, sclera or conjunctivae nor corrosion by the test item was observed.
The primary Eye Irritation Score for the test item was 0.11 (the maximum attainable score is 13.0).
Conclusion: The test item was not irritating in this study.
Executive summary:

Introduction: To assess the primary eye irritation potential of the test item, a primary eye irritation study was performed in three (one male and two females) young adult New Zealand White rabbits.

Methods: The left eye of each animal was exposed to the test item by instilling 0.1 g of the test item into the conjunctival sac. The treated eyes were not rinsed after instillation. Corneal, iridic, conjunctival and scleral irritation was evaluate at 1 , 24, 48 and 72 hours after instillation.

Results: The single instillation of the test item into the conjunctival sac caused mild, early-onset and transient ocular changes, such as slight reddening of the conjunctivae and sclerae as well as slight ocular discharge. These effects were reversible and were no longer evident 24 or 48 hours after treatment. No abnormal findings were observed in the cornea or iris of any animal at any of the examinations. No staining of the cornea, sclera or conjunctivae nor corrosion by the test item was observed. The primary Eye Irritation Score for the test item was 0.11 (the maximum attainable score is 13.0).

Conclusion: The test item was not irritating in this study.