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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
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. For read-across justification see Section 13.

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
- Physical state: liquid

- Nominal molecular formula (if other than submission substance): C35 H58 O6
- Nominal molecular weight (if other than submission substance): 574.85
- Nominal Smiles notation (if other than submission substance): O=C(c1ccc(cc1C(=O)O)C(=O)OCCCCCCCC)OCCCCCCCCCC
- Nominal InChl (if other than submission substance): 1S/C27H42O6/c1-3-5-7-9-11-12-14-16-20-33-27(31)23-18-17-22(21-24 (23)25(28)29)26(30)32-19-15-13-10-8-6-4-2/h17-18,21H,3-16,19-20H2,1-2H3, (H,28,29)

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 Safety of Chemicals in Foods, Drugs and Cosmetics, FDA, Austin, Texas 1959, page 51)


TOOL USED TO ASSESS SCORE: ophthalmic lamp, fluorescein 72 hours after administration

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritant / corrosive response data:
AVERAGE SCORE
- Cornea: 0.0
- Iris: 0.0
- Conjunctivae (Redness): 0.0
- Conjunctivae (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 classified
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 conjunctiva: 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:

Eye irritation of a structural analogue of the substance (1,2,4 -Benzenetricarboxylic acid, mixed decyl and octyl triesters) has been investigated in the rabbit using methods in accordance with OECD guideline 405.

Administration of 1,2,4 -Benzenetricarboxylic acid, mixed decyl and octyl triesters caused no irritation reactions of the cornea or iris. Mild conjunctival redness was seen in all animals after 1 hour and mild discharge was noted in one animal. 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 conjunctiva: 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.