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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2002-01-28 to 2002-02-02
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
17 July 1992
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
29 December 1992
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Bis(2-ethylhexyl) carbonate
EC Number:
238-925-9
EC Name:
Bis(2-ethylhexyl) carbonate
Cas Number:
14858-73-2
Molecular formula:
C17H34O3
IUPAC Name:
bis(2-ethylhexyl) carbonate
Test material form:
other: liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: no data
- Weight at study initiation: 3.78, 4.32 and 4.80 kg
- Housing: individual housing (100 x 45 x 40 cm, L x B x H) in a battery of cages, equipped with a paper roll disposal system
- Diet: ad libitum, standard laboratory rabbit diet Teklad Global Rabbit Diet (pelleted diet, batch no. H134) produced by Harlan Teklad, Shaw's farm, Blackthorn Bicester, Oxon, OX6 OTP, England
- Water: ad libitum, drinking water as for human consumption
- Acclimation period: about 2 months

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 2O +/- 3
- Humidity (%): 30 - 70
- Air changes (per hr): 16
- Photoperiod: Artificial light was set to give a cycle of 12 hours light and 12 hours dark with light on at 7.00 a.m.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Each animal served as its one control. The test article was introduced into the conjunctival sac of one eye, the untreated eye serving as a control.
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL
- Concentration: undiluted
Duration of treatment / exposure:
Eyes were not rinsed after treatment.
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
ADMINISTRATION OF THE TEST ARTICLE
- The liquid test article was used as supplied by the sponsor. One of the animals (rabbit no. 1) was treated in advance in order to assess ocular reactions to the test article. The animal was treated with 0.1 mL of the liquid test article, which was introduced into the conjunctival sac of the right eye after gently pulling the lower lid away from the eyeball. The lid was then gently held together for about 1 sec in order to limit loss of the test article. The untreated left eye served as control. Since there was no remarkable response to the instillation of the test article, the further two animals were treated subsequently in the same manner.

REMOVAL OF TEST SUBSTANCE
- Washing: no washing was done

SCORING SYSTEM: Draize scoring scheme as stipulated by OECD 405
In addition to the examination of the eyes, general clinical observation was conducted.

TOOL USED TO ASSESS SCORE: no tools mentioned

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal: #1, #2
Time point:
other: Mean 24, 48 and 72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: Mean 24, 48 and 72 h
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 4 days
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, #3
Time point:
other: Mean 24, 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: #1, #2, #3
Time point:
other: Mean 24, 48 and 72 h
Score:
0
Max. score:
2
Irritation parameter:
chemosis score
Basis:
animal: #1, #2, #3
Time point:
other: Mean 24, 48 and 72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
CLINICAL EYE OBSERVATION
- Slight or moderate redness and slight swelling of the conjunctivae were observed in all animals 1 h after instillation. Redness, slight or moderate in degree, was still apparent 24 h after instillation in the three rabbits and up to 72 h after instillation in rabbit no. 3. No ocular findings were seen on day 4 of the study.

REVERSIBILITY
- The observed findings were fully reversible within 4 days in all animals.
Other effects:
TOXIC EFFECTS OTHER THAN OCULAR IRRITATION/CORROSION
- No other toxic effects than slight ocular irritation were observed.

Any other information on results incl. tables

Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility

Cornea

Iris

Conjunctivae

Chemosis

Max. score: 4

Max. score: 2

Max. score: 3

Max. score: 4

60 min

0/0/0

0/0/0 

1/2/2

1/1/1

24 h

0/0/0

0/0/0

1/1/2 

 0/0/0 

48 h

0/0/0 

 0/0/0 

0/0/1

 0/0/0 

72 h

0/0/0 

0/0/0

0/0/1

 0/0/0 

4 days

0/0/0 

0/0/0

0/0/0

0/0/0

Average 24h, 48h, 72h

0/0/0 

0/0/0

0.33/0.33/1.33 

0/0/0 

Reversibility*)

 c/c/c

 c/c/c 

c/c/c

c/c/c

time for reversion

 

 

48h/ 48h/4d

 24h/24h/ 24h

 

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)
Conclusions:
Judgement is based on effects on the cornea, iris and conjunctiva calculated as mean scores following grading at 24, 48 and 72 hours after instillation of the test material, in consideration of reversibility.
The test substance is considered to be neither a seriously eye damaging substance nor an eye irritant according to CLP, EU GHS (Regulation (EC) No 1272/2008).
Executive summary:

In a primary eye irritation study according to OECD Guideline 405, 17 July 1992 and EU Method B.5, 29 December 1992, 0.1 mL of Bis(2-ethylhexyl) carbonate (approx. 100 % a.i.) was instilled into the conjunctival sac of three White New Zealand rabbits. The eyes were not rinsed after substance application. Animals then were observed for 4 days. Irritation was scored by the method of Draize as stipulated by OECD Guideline 405.

Slight or moderate redness and slight swelling of the conjunctivae were observed in all animals 1 h after instillation. Redness, slight or moderate in degree, was still apparent 24 h after instillation in the three rabbits and up to 72 h after instillation in rabbit no. 3. No ocular findings were seen on day 4 of the study. The observed findings were fully reversible within 4 days in all animals.

Calculated mean scores following grading at 24, 48 and 72 hours after installation of the test material for effects on the conjunctiva are 0.33 for two animals and 1.33 for the third animals. Mean scores for effects on the cornea as well as for effects on the iris were 0.0 for all animals.

The test substance Bis(2-ethylhexyl) carbonate is considered to be neither a seriously eye damaging substance nor an eye irritant according to CLP, EU GHS (Regulation (EC) No 1272/2008).

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