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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:
1994-11-07 to 1994-11-18
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): MARLOTHERM L, new
- Substance type: product
- Physical state: liquid
- Storage condition of test material: in a closed container in a laboratory hood

Test animals / tissue source

Species:
rabbit
Strain:
other: Small White Russian
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach, Germany
- Age at study initiation: adult, no furhter details mentioned
- Weight at study initiation: 2.3 - 2.9 kg
- Housing: conventional, singly in stainless steel cages
- Diet (e.g. ad libitum): K4 complete feed for rabbits ad libitum, supplied by Ssniff Spezialfutter GembH, Soest, Germany
- Water (e.g. ad libitum): Drinking water ad libitum, supplied by Gelsenwasse, Wasserwerk, Halten, Germany
- Acclimation period: at least 14 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 1994-11-07 To: 1994-11-18

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 cm³
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
1, 24, 48 and 72 hours, and 6, 8, 10 days after application
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm phyiological saline
- Time after start of exposure: 24 hours


SCORING SYSTEM: acording to guideline


TOOL USED TO ASSESS SCORE: ophtmalic lamp, fluorescein at the end of exposure

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: all
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: all
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal: all
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 6 days
Irritation parameter:
chemosis score
Basis:
animal: #2 and 3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 6 days
Irritant / corrosive response data:
AVERAGE SCORE
- Cornea: 0
- Iris: 0
- Conjuntivae (Redness): 0
- Conjuntivae (Chemosis): 0.89
Other effects:
After 1, 24 and 48 hour all animals showed distinct hyperamia of some blood vessels and slight conjuctival swelling. Exudation was observed after 1 hour in one animal. For up to 72 hours the animals showed swelling and redness of the skin of the outer eyelids, later on one animal had, in addition to scaling, bloodstained areas in places on this region of skin. In the other two animals at this time there was only slight redness and swelling of the skin of the outer eyelid, and scaling. After 10 days all animals were free of signs of irritation.

Any other information on results incl. tables

Table #: 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

 1/1/1

 1/1/1

24 h

 0/0/0

 0/0/0

 0/0/0

 1/1/1

48 h

 0/0/0

 0/0/0

 0/0/0

 1/1/1

72 h

 0/0/0

 0/0/0

 0/0/0

 0/1/1

Average 24h, 48h, 72h

 0

 0

 0

 0.89

Area effected

 -

-

 -

 -

Maximum average score (including area affected, max 110)

 0

 0

 0

Reversibility*)

 -

 c.

 c.

Average time (unit) for reversion

-

-

6 days

6 days

 

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

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item was slightly irritant when administered by ocular route to rabbits.
Executive summary:

The potential of benzyltoluene to induce ocular irritation was evaluated in rabbits according to OECD No. 405. Benzyltoluene was first administered to three male New Zealand White rabbit. A single dose of 0.1 mL of undiluted benzyltoluene was instilled into the conjunctival sac of one eye. The other eye was not treated and served as control. The eyes were not rinsed after administration of the test item. Ocular reactions were observed approximately 1 hour, 24, 48 and 72 hours after the administration and then daily until reversibility of the ocular reactions. The mean values of the scores for chemosis, redness of the conjunctiva, iris lesions and corneal opacity were calculated for each animal. After 1, 24 and 48 hour all animals showed distinct hyperamia of some blood vessels and slight conjuctival swelling. Exudation was observed after 1 hour in one animal. For up to 72 hours the animals showed swelling and redness of the skin of the outer eyelids, later on one animal had, in addition to scaling, bloodstained areas in places on this region of skin. In the other two animals at this time there was only slight redness and swelling of the skin of the outer eyelid, and scaling. After 10 days all animals were free of signs of irritation. Mean scores calculated for each animal over 24, 48 and 72 hours were (0.6) (1) and (1) for chemosis, (0) (0) and (0) for redness of the conjunctiva, (0) (0) and (0) for iris lesions and (0) (0) and (0) for corneal opacity. Under these experimental conditions, the test item was slightly irritant when administered by ocular route to rabbits.