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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:
December 1979 - March 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Equivalent to guideline study; the study passed a Quality Assurance audit (dated 1981-03-24)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Diallyl 2,2'-oxydiethyl dicarbonate
EC Number:
205-528-7
EC Name:
Diallyl 2,2'-oxydiethyl dicarbonate
Cas Number:
142-22-3
Molecular formula:
C12H18O7
IUPAC Name:
3-({[2-(2-{[(prop-2-en-1-yloxy)carbonyl]oxy}ethoxy)ethoxy]carbonyl}oxy)prop-1-ene
Details on test material:
- Name of test material (as cited in study report): 100% DDC (Diallyl Diglycol Carbonate)
- Substance type: organic
- Physical state: clear, colorless liquid
- Analytical purity: data not available
- Impurities (identity and concentrations): data not available
- Composition of test material, percentage of components:
- Isomers composition: data not available
- Purity test date: data not available
- Lot/batch No.: data not available
- Expiration date of the lot/batch: data not available
- Stability under test conditions: data not available
- Storage condition of test material: at room temperature in a locked test compound cabinet.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the left eye served as the untreated control
Duration of treatment / exposure:
a single exposure in one eye of albino rabbits
Observation period (in vivo):
All animals were observed closely for gross signs of systemic toxicity and mortality at frequent intervals during the day of dosing and at least twice daily thereafter for a ( total of 14 days. Room conditions as well as availability of adequate food and water were checked and any noteworthy conditions recorded.
Number of animals or in vitro replicates:
A total of nine rabbits (6 not rinsed and 3 rinsed) were used.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
of six animals
Time point:
other: 1 h
Score:
8
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: not rinsed
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
of three animals
Time point:
other: 1 h
Score:
3
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: rinsed
Irritation parameter:
chemosis score
Time point:
24/48/72 h
Remarks on result:
not determinable
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.33
Reversibility:
fully reversible within: 48 h
Other effects:
no

Any other information on results incl. tables

Body Weights

Body weights at the termination of the study ranged from 2.15 to 2.75 kilograms. Body weight changes appear to be normal.

Observations and Mortality

No animal exhibited signs of systemic toxicity and no deaths occurred during the investigation.

Necropsy

Evaluation of the test animals at necropsy by the pathologist revealed no significant gross pathologic findings.

Primary Eye Irritation Index

Means of individual irritation scores used to calculate the primary irritation index presented in Table 3 and 4.

Table 3: Primary Eye Irritation Index in Rabbits (not rinsed)

Tissue

Examination Intervals

1 h

6 h

24 h

48 h

72 h

4 Days

7 Days

Cornea

0

0

0

0

0

0

0

Iris

0

0

0

0

0

0

0

Conjunctiva

48

4

0

0

0

0

0

Total

48

4

0

0

0

0

0

Mean

8.0

0.67

0

0

0

0

0

Table 4: Primary Eye Irritation Index in Rabbits (rinsed)

Tissue

Examination Intervals

1 h

6 h

24 h

48 h

72 h

4 Days

7 Days

Cornea

0

0

0

0

0

0

0

Iris

0

0

0

0

0

0

0

Conjunctiva

18

4

2

0

0

0

0

Total

18

4

2

0

0

0

0

Mean

3.0

0.67

0.33

0

0

0

0

Positive scores only noted in the conjunctiva lasted through the 24-hour examination interval. No positive findings were noted upon further examination with fluorescein dye.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According method of Draize, when 100% DDC (diallyl diglycol carbonate) was instilled into one eye of each of nine albino rabbits (6 not rinsed and 3 rinsed) the primary eye irritation index was determined to be 8.0 and was classified as minimally irritating. Instillation of water into the treated eyes of three rabbits did not change the classification but decreased the score to 3.0. According to the guidance to Regulation (EC) No 1272/2008 (CLP Regulation) [ECHA Guidance on the Application of the CLP Criteria, Aug 2009; p. 249], Diallyl Diglycol Carbonate does not meet criteria for classification as eye irritant.
Executive summary:

The objective of this study was to determine the irritative potential of the test material following a single exposure in one eye of albino rabbits. Nine rabbits (6 not rinsed and 3 rinsed) were used.

0.1 mL of undiluted test material was instilled in the right eye of each animal. All animals were observed for signs of systemic toxicity and mortality until sacrifice on day 14. Body weights on the day of exposure and the termination were recorded. A gross necropsy were performed on the visceral and thoracic cavities. Primary Eye Irritation Index was calculated using the standard scoring system of Draize.

No positive findings were noted in two ocular tissues: cornea and iris. Positive scores were only noted in the conjunctiva lasted through 24 -hour interval. The one-hour interval provided the highest mean score (8.0) for 100% DDC (diallyl diglycol carbonate) and was therefore used as the primary irritation index and classified the test compound as minimally irritating using the method of Draize. Instillation of water into the treated eyes of three rabbits did not change the classification but decreased the mean score to 3.0.