Diisotridecyl phthalate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1984-02-13 to 1984-03-05

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable well-documented study report which meets basic scientific principles and was performed according to internationally accepted testing guidelines.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Diisotridecyl phthalate

EC Number:

248-368-3

EC Name:

Diisotridecyl phthalate

Cas Number:

27253-26-5

Molecular formula:

C34H58O4

IUPAC Name:

1,2-bis(2-methyldodecyl) benzene-1,2-dicarboxylate

Details on test material:

- Name of test material (as cited in study report): Vestinol TD stabilised with 0.5% Bisphenol A
- Substance type: product
- Impurities (identity and concentrations): 0.4% Tridecanole, 0.45% Bisphenol A
- Physical state: liquid
- Lot/batch No.: T 53/124312173
- Other: Date of production: 1983-09-01

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: 2.5 - 2.7 kg
- Housing: conventional, singly in stainless steel cages
- Diet: K4 complete feed for rabbits ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany
- Water: 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

IN-LIFE DATES: From: 1984-02-13 To: 1984-03-05

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 mL

Duration of treatment / exposure:

The test substance was not washed out.

Observation period (in vivo):

21 days
assessment at 1, 24, 48 and 72 hours, and 7, 10 and 21 days after application.

Number of animals or in vitro replicates:

In the description of the test method 10 animals (5 male, 5 female) were mentioned. In the result tables however, 6 animals
(3 male, 3 female) were evaluated.

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: no
SCORING SYSTEM: according to guideline
TOOL USED TO ASSESS SCORE: ophthalmic lamp, fluorescein solution on day 21

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 1, 24, 48 and 72 hours

Score:

2.17

Max. score:

110

Results 2

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: Average 24, 48 and 72 hours

Score:

0

Results 3

Irritation parameter:

iris score

Basis:

mean

Time point:

other: Average 24, 48 and 72 hours

Score:

0

Results 4

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: Average 24, 48 and 72 hours

Score:

0.11

Reversibility:

fully reversible within: 48 hours

Results 5

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: Average 24, 48 and 72 hours

Score:

0

Irritant / corrosive response data:

AVERAGE SCORE (24, 48 and 72 hours)
- Cornea: 0
- Iris: 0
- Conjuntivae (Redness): 0.11
- Conjuntivae (Chemosis): 0

Other effects:

The treated eye of one male animal showed a decrease of the normal brightness. A small clouded bar on the cornea of this
animal were also noted, which persisted for the whole observation period.

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 Max. score: 4	Iris Max. score: 2	Conjunctivae Max. score: 3	Chemosis Max. score: 4
60 min	0/0/0/0/0/0	0/0/0/0/0/0	2/2/2/2/2/2	0/0/0/0/0/0
24 h	0/0/0/0/0/0	0/0/0/0/0/0	1/0/0/1/0/0	0/0/0/0/0/0
48 h	0/0/0/0/0/0	0/0/0/0/0/0	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	0/0/0/0/0/0	0/0/0/0/0/0
Average 24h, 48h, 72h	0	0	0.11	0
Area effected	-	-	-	-
Maximum average score (including area affected, max 110)	0	0	2.17	0
Reversibility *)	-	-	c.	-
Average time (unit) for reversion	-	-	48 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: expert judgment

Conclusions:

Based on observation made at 24, 48, and 72 hours post exposure, this substance is not considered an eye irritant.

Executive summary:

In this study, rabbits were exposed to DTDP to assess eye irritation. A dose of 0.1 ml of test material was introduced into one eye of each animal. The test substance was not washed out. Assessment of eye irritation occurred at 1, 24, 48 and 72 hours post exposure. Most animals had slight ocular irritation (conjunctivae) at 1 hour post exposure. None of the animals exhibited positive scores for ocular irritation at 48 hours, and all animals were free of signs of ocular irritation within 48 hours post instillation.