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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 1994-11-11
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
Test material form:
liquid
Details on test material:
Test was performed with dibenzyltoluene, new name: dibenzylbenzene, ar-methyl derivative

Test animals / tissue source

Species:
rabbit
Strain:
other: Small White Russian, Chbb:HM, SPF
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach, Germany
- Age at study initiation: young healthy adults, no further details mentioned
- Weight at study initiation: Animal 1: 2.3 kg, animal 2: 2.4 kg, animal 3: 2.2 kg
- Housing: conventionally, one animal/steel cage
- Diet (e.g. ad libitum): K 4, Special feed for rabbits ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): Drinking water ad libitum, supplied by Gelsenwasser, Wasserwerk, Haltern, 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: 1994-11-11

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 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: according to guideline

TOOL USED TO ASSESS SCORE: ophtmalic lamp, fluorescein 24 hours after administration

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Irritant / corrosive response data:
AVERAGE SCORE
- Cornea: 0
- Iris: 0
- Conjuntivae (Redness): 0
- Conjuntivae (Chemosis): 0
Other effects:
After 1 hour all animals showed hyperamic blood vessels and a slight swelling of the conjuctivae, furthermore discharge different from normal were observed. Cornea and iris showed no changes.

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for each animal at each observation time of each animal from the test

Score at time point / Reversibility

Cornea

Iris

Conjunctivae

Chemosis

Max. score: 0

Max. score: 0

Max. score: 1

Max. score: 1

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 

0/0/0

48 h

0/0/0

0/0/0 

0/0/0 

0/0/0

72 h

0/0/0

0/0/0 

0/0/0 

0/0/0

Average 24h, 48h, 72h

 0

 0

 0

Area effected

 

 

 

 

Maximum average score (including area affected, max 110)

 

 

 

 

Reversibility*)

 

 

 c.

 c.

Average time (unit) for reversion

 

 

 

 

 

*) 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: OECD GHS
Conclusions:
The test substance was found to be only very slightly irritating shortly after treatment, not fulfilling the criteria for classification. All effects disappeared shortly after treatment.
Executive summary:

The test substance was tested for eye irritation in rabbits in an OECD 405 guideline study and was found to be only very slightly irritating shortly after test substance application. No effects were observed at observation times 24hr, 48hr and 72 hr after application.