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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:
22.10.2009 to 04.01.2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
impurity
Test material form:
solid
Specific details on test material used for the study:
4-(Methacryloyloxy) bezophenone 97.3 %
Benzophenone acetate: 1.95 %

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Remarks:
Healthy New Zealand White Rabbits, Crl: KBL (NZW)
Details on test animals or tissues and environmental conditions:
Sex: female
Body weight at the beginning of the study: > 2 kg
Age at the beginning of the study: approximately 18 weeks old
Number of animals: 3
The animals were derived from a controlled full barrier maintained breeding system
(SPF). According to Art. 9.2, No.7 of the German Act on Animal Welfare the animals were bred for experimental purposes.

Housing and Feeding Conditions
Semi-barrier in an air-conditioned room Temperature: 18 ± 3°C (recommendations ofTVT, GV-SOLAS;
Relative humidity: 55± 10%
Artificial light, sequence being 12 hours light, 12 hours dark
Air change: at least 10 x / hour
Free access to autoclaved hay and to Altromin 2123 maintenance diet for rabbits (lot no. 1411 ), rich in crude fibre
Free access to tap water (drinking water, municipal residue control, microbial.controlled periodically)
Housed in ABS - plastic rabbit cages, floor 4200 cm2
Adequate acclimatisation period (at least 5 days)

Test system

Controls:
yes, concurrent no treatment
Amount / concentration applied:
0,1 g per test site.
The test item was ground to a fine dust using a mortar and pestle. It was applied directly.
Observation period (in vivo):
The animals were observed for 72 hours after dosing.
Number of animals or in vitro replicates:
3
Details on study design:
Application
The test item was applied at a single dose in the conjunctival sac of one eye of each test animal after pulling the lower lid away from the eyeball. The lids were then gently held together for about 1 second in order to prevent loss of the material. The untreated contralateral eye served as control. Only part of the test item was applied as the full amount did not fit into the eye completely.
Confirmatory Test
The results of the initial test did not indicate the test item to be corrosive or a severe irritant to the eye using the procedure described. In order to confirm the response.
The eyes were not rinsed.

The eyes were examined for signs of irritation throughout the observation period.
For the calculation only the 24, 48 and 72 hour readings were used.
At the end of the observation period the treated eyes were examined with the aid of a fluorescein solution (Fluoreszein SE Thilo®, lot no. H 901, expiry date: 12/2010).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: #1, #2, #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal: #1, #2, #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal: #1, #2, #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
The test item produced ilTitant, but no cotTosive ocular effects after instillation into the eyes of3 female rabbits (strain NZW) (Tables 3 to 5).
Neither mortalities nor significant clinical signs of toxicity were observed.
The eyes were not rinsed.
Upon fluorescein examinations at the end of the observation period of 72 h no corneal lesions were found in any animal.
1 h post application, conjunctival discharge grade 2 was observed in animal no. 1, conjunctival discharge grade 1 was observed in animals no. 2 and 3.
Conjunctival redness and chemosis were also observed in animal no. 1, 2 and 3,

Any other information on results incl. tables

Eye irritation scores animal no.1

Animal no. 1

 

Single data

Average score (24, 48 and 72 h)

 

Time post application

 

 

1 hour

24 hour

48 hour

72 hour

 

 

T/C

T/C

T/C

T/C

 

Cornea

0/0

0/0

0/0

0/0

0

Iris

0/0

0/0

0/0

0/0

0

Conjunctival redness

1/0

1/0

0/0

0/0

0.33

Conjunctival chemosis

1/0

0/0

0/0

0/0

0

 

Eye irritation scores animal no.2

Animal no. 2

 

Single data

Average score (24, 48 and 72 h)

 

Time post application

 

 

1 hour

24 hour

48 hour

72 hour

 

 

T/C

T/C

T/C

T/C

 

Cornea

0/0

0/0

0/0

0/0

0

Iris

0/0

0/0

0/0

0/0

0

Conjunctival redness

1/0

1/0

0/0

0/0

0.33

Conjunctival chemosis

1/0

0/0

0/0

0/0

0

 

Eye irritation scores animal no.2

 

Animal no. 3

 

Single data

Average score (24, 48 and 72 h)

 

Time post application

 

 

1 hour

24 hour

48 hour

72 hour

 

 

T/C

T/C

T/C

T/C

 

Cornea

0/0

0/0

0/0

0/0

0

Iris

0/0

0/0

0/0

0/0

0

Conjunctival redness

1/0

1/0

0/0

0/0

0.33

Conjunctival chemosis

1/0

0/0

0/0

0/0

0

 

T=test item, C=control

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the present study, single ocular instillation of the test item 4-(Methacryloyloxy)benzophenone to rabbits at a dose of 0.1 g produced slight irritant effects, which were fully reversible within 48 hours in all animals.
Neither mortalities nor significant clinical signs of toxicity were observed.
In conformity with the EC criteria for classification and labelling requirements for dangerous substances and preparations according to Annex VI of Commission Directive 2001159/EC and Annex I of Regulation (EC) 1272/2008, the test item 4-(Methacryloyloxy )benzophenone does not have to be classified and has no obligatory labelling requirement for eye irritation
Executive summary:

In an eye irritation/corrosion study with 4-(Methacryloyloxy)benzophenone acc. OECD 405,single ocular instillation of the test item 4-(Methacryloyloxy)benzophenone to rabbits at a dose of 0.1 g produced slight irritant effects, which were fully reversible within 48 hours in all animals. Neither mortalities nor significant clinical signs of toxicity were observed.

In conformity with the EC criteria for classification and labelling requirements for dangerous substances and preparations according to Annex VI of Commission Directive 2001159/EC and Annex I of Regulation (EC) 1272/2008, the test item 4-(Methacryloyloxy )benzophenone does not have to be classified and has no obligatory labelling requirement for eye irritation