Magnesium, bis[2-(hydroxy-.kappa.O)benzoato-.kappa.O]-, ar, ar'-di-C14-18-alkyl derivs.

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1986-10-06 to 1987-01-10

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Meets generally accepted scientific standards, is well documented and acceptable for assessment. Combined study and thus reporting lacking in some details, hence restrictions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Magnesium, bis(2-hydroxybenzoato-O1,O2)-, ar,ar'-di-C14-18alkyl derivs.

EC Number:

931-371-5

Cas Number:

171171-80-5

IUPAC Name:

Magnesium, bis(2-hydroxybenzoato-O1,O2)-, ar,ar'-di-C14-18alkyl derivs.

Details on test material:

- Name of test material (as cited in study report): [CAS Number 171171-80-5]
- Physical state: Dark brown viscous liquid
- Lot/batch No.: XSA 053J
- Storage condition of test material: In the dark at ambient temperature
- Stability under test conditions: Infra-red spectra taken on 14 August 1986 and 18 December 1986 showed no differences and the substance was judged to have been stable for the duration of the study

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Sittingbourne Research Centre Breeding Unit
- Age at study initiation: 3-6 months
- Weight at study initiation: 3664-3860 g (males) and 2952-3460 g (females)
- Housing: Singly in hanging, stainless steel cages with all-mesh floors and tops and half-mesh fronts; each cage measuring 67 cm x 43 cm x 45 cm. The cages were mounted in three rows of two on a single-sided rack (a total of six cages).
- Diet: Standard Rabbit Diet, SQC, Special Diet Services Ltd, Essex) ad libitum by means of a top loading food hopper
- Water: Filtered but untreated water from the public supply ad libitum by means of an automatic valve-regulated drinking line
- Acclimation period: = 2 weeks

ENVIRONMENTAL CONDITIONS
- Temperature: 16-19 degrees Centigrade
- Photoperiod: Automatically controlled cycle of light (06:00 to 18:00) and dark (18:00 to 06:00)

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

Single dose

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

Three males and three females

Details on study design:

Each rabbit was identified by means of a anumbered metal ear tag and/or a number written on the pinna. The day before testing the eyes of the rabbits were carefully examined for any damage, and any animals showing damage were replaced. The undiluted test material was placed into the lower conjunctival sac of one eye of each rabbit and the lids held together for a few seconds to prevent loss of material. The eyes were not washed. The reactions of the animals were observed immediately after instillation and the initial pain response graded as shown in the scoring criteria (attached).

A visual assessment of eye irritancy was made at 1 h, 4-7 h, 24 h, 48 h, 72 h, and 7 d after instillation. Irritancy was scored for the cornea, iris and conjunctivae using the standard scores attached. At 24 h, and in the event of any corneal damage, visualisation was aided by the instillation of one drop of 2 % flurescein solution.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

animal: 870M

Time point:

other: 1 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7 d

Results 2

Irritation parameter:

conjunctivae score

Basis:

animal: 870M

Time point:

other: 4h

Score:

1

Max. score:

1

Reversibility:

fully reversible

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal: 870M

Time point:

24 h

Score:

2

Max. score:

2

Reversibility:

fully reversible

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal: 870M

Time point:

48 h

Score:

1

Max. score:

1

Reversibility:

fully reversible

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal: 870M

Time point:

72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal: 870M

Time point:

7 d

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal: 871M

Time point:

other: 1h

Score:

2

Max. score:

2

Reversibility:

fully reversible

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal: 871M

Time point:

other: 4h

Score:

2

Max. score:

2

Reversibility:

fully reversible

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal: 871M

Time point:

24 h

Score:

2

Max. score:

2

Reversibility:

fully reversible

Results 10

Irritation parameter:

conjunctivae score

Basis:

animal: 871M

Time point:

48 h

Score:

1

Max. score:

1

Reversibility:

fully reversible

Results 11

Irritation parameter:

conjunctivae score

Basis:

animal: 871M

Time point:

72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 12

Irritation parameter:

conjunctivae score

Basis:

animal: 871M

Time point:

7 d

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 13

Irritation parameter:

conjunctivae score

Basis:

animal: 872M

Time point:

other: 1h

Score:

2

Max. score:

2

Reversibility:

fully reversible

Results 14

Irritation parameter:

conjunctivae score

Basis:

animal: 872M

Time point:

other: 4h

Score:

2

Max. score:

2

Reversibility:

fully reversible

Results 15

Irritation parameter:

conjunctivae score

Basis:

animal: 872M

Time point:

24 h

Score:

2

Max. score:

2

Reversibility:

fully reversible

Results 16

Irritation parameter:

conjunctivae score

Basis:

animal: 872M

Time point:

48 h

Score:

1

Max. score:

1

Reversibility:

fully reversible

Results 17

Irritation parameter:

conjunctivae score

Basis:

animal: 872M

Time point:

72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible

Results 18

Irritation parameter:

conjunctivae score

Basis:

animal: 872M

Time point:

7 d

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 19

Irritation parameter:

conjunctivae score

Basis:

animal: 885F

Time point:

other: 1h

Score:

2

Max. score:

2

Reversibility:

fully reversible

Results 20

Irritation parameter:

conjunctivae score

Basis:

animal: 885F

Time point:

other: 4h

Score:

2

Max. score:

2

Reversibility:

fully reversible

Results 21

Irritation parameter:

conjunctivae score

Basis:

animal: 885F

Time point:

24 h

Score:

2

Max. score:

2

Reversibility:

fully reversible

Results 22

Irritation parameter:

conjunctivae score

Basis:

animal: 885F

Time point:

48 h

Score:

1

Max. score:

1

Reversibility:

fully reversible

Results 23

Irritation parameter:

conjunctivae score

Basis:

animal: 885F

Time point:

72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible

Results 24

Irritation parameter:

conjunctivae score

Basis:

animal: 885F

Time point:

7 d

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 25

Irritation parameter:

conjunctivae score

Basis:

animal: 886F

Time point:

other: 1h

Score:

1

Max. score:

1

Reversibility:

fully reversible

Results 26

Irritation parameter:

conjunctivae score

Basis:

animal: 886F

Time point:

other: 4h

Score:

1

Max. score:

1

Reversibility:

fully reversible

Results 27

Irritation parameter:

conjunctivae score

Basis:

animal: 886F

Time point:

24 h

Score:

2

Max. score:

2

Reversibility:

fully reversible

Results 28

Irritation parameter:

conjunctivae score

Basis:

animal: 886F

Time point:

48 h

Score:

1

Max. score:

1

Reversibility:

fully reversible

Results 29

Irritation parameter:

conjunctivae score

Basis:

animal: 886F

Time point:

72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 30

Irritation parameter:

conjunctivae score

Basis:

animal: 886F

Time point:

7 d

Score:

0

Max. score:

0

Reversibility:

not specified

Results 31

Irritation parameter:

conjunctivae score

Basis:

animal: 887F

Time point:

other: 1h

Score:

1

Max. score:

1

Reversibility:

fully reversible

Results 32

Irritation parameter:

conjunctivae score

Basis:

animal: 887F

Time point:

other: 4h

Score:

2

Max. score:

2

Reversibility:

fully reversible

Results 33

Irritation parameter:

conjunctivae score

Basis:

animal: 887F

Time point:

24 h

Score:

2

Max. score:

2

Reversibility:

fully reversible

Results 34

Irritation parameter:

conjunctivae score

Basis:

animal: 887F

Time point:

48 h

Score:

1

Max. score:

1

Reversibility:

fully reversible

Results 35

Irritation parameter:

conjunctivae score

Basis:

animal: 887F

Time point:

72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 36

Irritation parameter:

conjunctivae score

Basis:

animal: 887F

Time point:

7 d

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 37

Irritation parameter:

chemosis score

Basis:

animal: 870M

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 38

Irritation parameter:

chemosis score

Basis:

animal: 871M

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 39

Irritation parameter:

chemosis score

Basis:

animal: 872M

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 40

Irritation parameter:

chemosis score

Basis:

animal: 885F

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 41

Irritation parameter:

chemosis score

Basis:

animal: 886F

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 42

Irritation parameter:

chemosis score

Basis:

animal: 887F

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 43

Irritation parameter:

iris score

Basis:

animal: 870M

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

not specified

Results 44

Irritation parameter:

iris score

Basis:

animal: 871M

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

not specified

Results 45

Irritation parameter:

iris score

Basis:

animal: 872M

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

not specified

Results 46

Irritation parameter:

iris score

Basis:

animal: 885F

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

not specified

Results 47

Irritation parameter:

iris score

Basis:

animal: 886F

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

not specified

Results 48

Irritation parameter:

iris score

Basis:

animal: 887F

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

not specified

Results 49

Irritation parameter:

cornea opacity score

Basis:

animal: 870M

Time point:

other: 1h

Score:

1

Max. score:

1

Reversibility:

fully reversible

Results 50

Irritation parameter:

cornea opacity score

Basis:

animal: 870M

Time point:

other: 4h

Score:

1

Max. score:

1

Reversibility:

fully reversible

Results 51

Irritation parameter:

cornea opacity score

Basis:

animal: 870M

Time point:

24 h

Score:

1

Max. score:

1

Reversibility:

fully reversible

Results 52

Irritation parameter:

cornea opacity score

Basis:

animal: 870M

Time point:

48 h

Score:

1

Max. score:

1

Reversibility:

fully reversible

Results 53

Irritation parameter:

cornea opacity score

Basis:

animal: 870M

Time point:

72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible

Results 54

Irritation parameter:

cornea opacity score

Basis:

animal: 870M

Time point:

7 d

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 55

Irritation parameter:

cornea opacity score

Basis:

animal: 871M

Time point:

other: 1h

Score:

0

Max. score:

0

Reversibility:

not specified

Results 56

Irritation parameter:

cornea opacity score

Basis:

animal: 871M

Time point:

other: 4h

Score:

0

Max. score:

0

Reversibility:

not specified

Results 57

Irritation parameter:

cornea opacity score

Basis:

animal: 871M

Time point:

24 h

Score:

0

Max. score:

0

Reversibility:

not specified

Results 58

Irritation parameter:

cornea opacity score

Basis:

animal: 871M

Time point:

48 h

Score:

0

Max. score:

0

Reversibility:

not specified

Results 59

Irritation parameter:

cornea opacity score

Basis:

animal: 871M

Time point:

72 h

Score:

0

Max. score:

0

Reversibility:

not specified

Results 60

Irritation parameter:

cornea opacity score

Basis:

animal: 871M

Time point:

7 d

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 61

Irritation parameter:

cornea opacity score

Basis:

animal: 872M

Time point:

other: 1h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 62

Irritation parameter:

cornea opacity score

Basis:

animal: 872M

Time point:

other: 4h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 63

Irritation parameter:

cornea opacity score

Basis:

animal: 872M

Time point:

24 h

Score:

1

Max. score:

1

Reversibility:

fully reversible

Results 64

Irritation parameter:

cornea opacity score

Basis:

animal: 872M

Time point:

48 h

Score:

1

Max. score:

1

Reversibility:

fully reversible

Results 65

Irritation parameter:

cornea opacity score

Basis:

animal: 872M

Time point:

72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 66

Irritation parameter:

cornea opacity score

Basis:

animal: 872M

Time point:

7 d

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 67

Irritation parameter:

cornea opacity score

Basis:

animal: 885F

Time point:

other: 1h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 68

Irritation parameter:

cornea opacity score

Basis:

animal: 885F

Time point:

other: 4h

Score:

1

Max. score:

1

Reversibility:

fully reversible

Results 69

Irritation parameter:

cornea opacity score

Basis:

animal: 885F

Time point:

24 h

Score:

1

Max. score:

1

Reversibility:

fully reversible

Results 70

Irritation parameter:

cornea opacity score

Basis:

animal: 885F

Time point:

48 h

Score:

1

Max. score:

1

Reversibility:

fully reversible

Results 71

Irritation parameter:

cornea opacity score

Basis:

animal: 885F

Time point:

72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible

Results 72

Irritation parameter:

cornea opacity score

Basis:

animal: 885F

Time point:

7 d

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 73

Irritation parameter:

cornea opacity score

Basis:

animal: 886F

Time point:

other: 1h

Score:

0

Max. score:

0

Reversibility:

not specified

Results 74

Irritation parameter:

cornea opacity score

Basis:

animal: 886F

Time point:

other: 4h

Score:

0

Max. score:

0

Reversibility:

not specified

Results 75

Irritation parameter:

cornea opacity score

Basis:

animal: 886F

Time point:

24 h

Score:

0

Max. score:

0

Reversibility:

not specified

Results 76

Irritation parameter:

cornea opacity score

Basis:

animal: 886F

Time point:

48 h

Score:

0

Max. score:

0

Reversibility:

not specified

Results 77

Irritation parameter:

cornea opacity score

Basis:

animal: 886F

Time point:

72 h

Score:

0

Max. score:

0

Reversibility:

not specified

Results 78

Irritation parameter:

cornea opacity score

Basis:

animal: 886F

Time point:

7 d

Score:

0

Max. score:

0

Reversibility:

not specified

Results 79

Irritation parameter:

cornea opacity score

Basis:

animal: 887F

Time point:

other: 1h

Score:

0

Max. score:

0

Reversibility:

not specified

Results 80

Irritation parameter:

cornea opacity score

Basis:

animal: 887F

Time point:

other: 4h

Score:

0

Max. score:

0

Reversibility:

not specified

Results 81

Irritation parameter:

cornea opacity score

Basis:

animal: 887F

Time point:

24 h

Score:

0

Max. score:

0

Reversibility:

not specified

Results 82

Irritation parameter:

cornea opacity score

Basis:

animal: 887F

Time point:

48 h

Score:

0

Max. score:

0

Reversibility:

not specified

Results 83

Irritation parameter:

cornea opacity score

Basis:

animal: 887F

Time point:

72 h

Score:

0

Max. score:

0

Reversibility:

not specified

Results 84

Irritation parameter:

cornea opacity score

Basis:

animal: 887F

Time point:

7 d

Score:

0

Max. score:

0

Reversibility:

not specified

Irritant / corrosive response data:

Instillation of the undiluted test substance into the conjunctival sac of one eye did not cause a pain response in any of the six rabbits. One rabbit (870 M) had opacity in a small area of the cornea within 1 h of dosing at which time all rabbits had minimal to moderate conjunctival redness, which persisted (or had increased) at 24 h post dosing. At this time, two rabbits (872 M and 885 M) had developed opacity of the cornea but this and all other ocular effects had cleared by 7 d post dosing.

Any other information on results incl. tables

The effect of the test material on rabbit eyes is summarised in Table 4 (attached).

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: experimental observation

Conclusions:

On administration of the test material there was no initial pain response. The test material caused moderate conjunctival redness initially in all six rabbits and minimal corneal opacity in three rabbits. All effects had cleared by 7 days and the test material was therefore considered only a very mild irritant to rabbit eyes.