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EC number: 248-654-8 | CAS number: 27776-01-8
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- Irritation / corrosion
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- Additional toxicological data

Eye irritation
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:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Benzyltoluene
- EC Number:
- 248-654-8
- EC Name:
- Benzyltoluene
- Cas Number:
- 27776-01-8
- Molecular formula:
- C14H14
- IUPAC Name:
- 1-benzyl-2-methylbenzene; 1-benzyl-3-methylbenzene; 1-benzyl-4-methylbenzene
- Reference substance name:
- MARLOTHERM L, neu
- IUPAC Name:
- MARLOTHERM L, neu
- 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
Constituent 1
Constituent 2
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 |
2 |
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.
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