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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:
1989-05-09 to 1989-05-16
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Witamol 218
- Substance type: product
- Physical state: liquid
- Stability under test conditions: not mentioned
- Storage condition of test material: not mentioned
- Other: none

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: not mentioned
- Weight at study initiation: 2.0 - 2.2 kg
- Housing: conventional, singly in stainless steel cages
- Diet (e.g. ad libitum): K4 complete feed for rabbits ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): Drinking water ad libitum
- Acclimation period: 14 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

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:
72 hours
Observation period (in vivo):
1, 24, 48 and 72 h and 7 days after treatment
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm physiological saline
- Time after start of exposure: 72 hours


SCORING SYSTEM: according to Draize (Appraisals of the Saftey of Chemicals in Foods, Drugs and Cosmetics, FDA, Austin, Texas 1959, page 51)


TOOL USED TO ASSESS SCORE: ophtmalic lamp, fluorescein 72 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: 0.0
- Iris: 0.0
- Conjuntivae (Redness): 0.0
- Conjuntivae (Chemosis): 0.0

Other effects:
DESCRIPTION OF LESIONS: 1 hour after application circumcorneal injections in all animals and mild discharge in one animal

Any other information on results incl. tables

Table #: 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: 4

Max. score: 2

Max. score: 3

Max. score: 4

60 min

0/0/0

 0/0/0

 1/1/1

 0/0/0

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

 0

Area effected

 -

 -

 -

 -

Maximum average score (including area affected, max 110)

 0

 0

 2.67

 0

Reversibility*)

 -

 -

 c.

 -

Average time (unit) for reversion

 -

 -

 24 hours

 -

 

*) 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: EU
Conclusions:
The following mean values, based on the results from the 24 -, 48 - and 72 hour-readings were calculated:
Cornea opacity: 0.0
Iris lesion: 0.0
Redness of conjuntiva: 0.0
Oedema of conjunctiva: 0.0
Based on the result of this study 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters was judged to be non irritating to eyes and mucosa.
Executive summary:

To test the acute irritant effect of 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters on the eyes and mucosa, 0.1 cm³ of the liquid test substance was administered into the conjunctival sac of one eye of each of three male rabbits. After exposure for 72 hours, the eyes were washed out with warm physiological saline. The test was carried out according to OECD guideline 405 (12 May 1982).

The test showed that administration of 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters caused no irritation reactions at cornea and iris. At the conjunctivae 1 hour after application circumcorneal injections in all animals and mild discharge in one animal were observed, after 24 hours all animals were free of symptoms.

The following mean values, based on the results from the 24 -, 48 - and 72 hour-readings were calculated:

Cornea opacity: 0.0

Iris lesion: 0.0

Redness of conjuntiva: 0.0

Oedema of conjunctiva: 0.0

Based on the result of this study 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters was judged to be non irritating to eyes and mucosa.