Reaction mass of propylidynetrimethanol and 2-ethylpropane-1,3-diol and 5-ethyl-1,3-dioxane-5-methanol

Eye irritation

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:

06 July 1992 - 21 July 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted to OECD test guidelines, and a statement of GLP compliance was included.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

4: rabbits used

GLP compliance:

yes

Remarks:

Report states that the testing laboratory, Scantox, was accredited by the Danish Accreditation Scheme, however a formal certificate of accreditation was not included.

Test material

Test material information

Constituent 1

Reference substance name:

CTF

IUPAC Name:

CTF

Test animals / tissue source

Species:

rabbit

Strain:

other: SPF albino

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Møllegard Breeding Centre ApS, Ejby, DK-4623 Lille Skensved.
- Age at study initiation: Not detailed
- Weight at study initiation: 2.5 - 2.7 kg.
- Housing: Animals were kept in single PPL cages, 45 x 55 cm, with perforated floor.
- Diet (e.g. ad libitum): The rabbits had free access to food pellets "Altromin 2123"
- Water (e.g. ad libitum): Free access to drinking water acidified with hydrochloric acid, to pH 2.5.
- Acclimation period: At least one week.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3°C
- Humidity (%): 55 ± 15%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 hours light (from 6h until 18h)


IN-LIFE DATES: From: 06 July 1992 To: 21 July 1992

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL (neat test substance).

Duration of treatment / exposure:

Single exposure.

Observation period (in vivo):

14 days (observations made 1, 24, 48, and 72 hours after exposure, and on days 7 and 14).

Number of animals or in vitro replicates:

Four females

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No data.

SCORING SYSTEM: Broadly consistent with the system described in OECD test guideline 405.


TOOL USED TO ASSESS SCORE: Hand held inspection lamp fitted with white and UV-light and a magnifying glass, and fluorescein.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Remarks:

(Cornea opacity)

Basis:

mean

Time point:

other: Mean of 24, 48, and 72 hour timepoints

Score:

1.75

Max. score:

2

Reversibility:

fully reversible within: 14 days

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: Mean of 24, 48, and 72 hour timepoints

Score:

0.08

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Results 3

Irritation parameter:

chemosis score

Remarks:

(Oedema of conjunctivae)

Basis:

mean

Time point:

other: Mean of 24, 48, and 72 hour timepoints

Score:

2.08

Max. score:

3

Reversibility:

fully reversible within: 14 days.

Results 4

Irritation parameter:

conjunctivae score

Remarks:

(Redness)

Basis:

mean

Time point:

other: Mean of 24, 48, and 72 hour timepoints

Score:

2.83

Max. score:

3

Reversibility:

fully reversible within: 14 days

Results 5

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 14 days

Results 6

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

48 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 14 days

Results 7

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 14 days

Results 8

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 14 days

Results 9

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

48 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 14 days

Results 10

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 14 days

Results 11

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 14 days

Results 12

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

48 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 14 days

Results 13

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 14 days

Results 14

Irritation parameter:

cornea opacity score

Basis:

animal #4

Time point:

24 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 14 days

Results 15

Irritation parameter:

cornea opacity score

Basis:

animal #4

Time point:

48 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 14 days

Results 16

Irritation parameter:

cornea opacity score

Basis:

animal #4

Time point:

72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 14 days

Results 17

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24 h

Score:

0

Max. score:

0

Results 18

Irritation parameter:

iris score

Basis:

animal #1

Time point:

48 h

Score:

0

Max. score:

0

Results 19

Irritation parameter:

iris score

Basis:

animal #1

Time point:

72 h

Score:

0

Max. score:

0

Results 20

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24 h

Score:

0

Max. score:

0

Results 21

Irritation parameter:

iris score

Basis:

animal #2

Time point:

48 h

Score:

0

Max. score:

0

Results 22

Irritation parameter:

iris score

Basis:

animal #2

Time point:

72 h

Score:

0

Max. score:

0

Results 23

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24 h

Score:

0

Max. score:

0

Results 24

Irritation parameter:

iris score

Basis:

animal #3

Time point:

48 h

Score:

0

Max. score:

0

Results 25

Irritation parameter:

iris score

Basis:

animal #3

Time point:

72 h

Score:

0

Max. score:

0

Results 26

Irritation parameter:

iris score

Basis:

animal #4

Time point:

24 h

Score:

0

Max. score:

0

Results 27

Irritation parameter:

iris score

Basis:

animal #4

Time point:

48 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Results 28

Irritation parameter:

iris score

Basis:

animal #4

Time point:

72 h

Score:

0

Max. score:

0

Results 29

Irritation parameter:

conjunctivae score

Remarks:

Erythema

Basis:

animal #1

Time point:

24 h

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 14 days

Results 30

Irritation parameter:

conjunctivae score

Remarks:

Erythema

Basis:

animal #1

Time point:

48 h

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 14 days

Results 31

Irritation parameter:

conjunctivae score

Remarks:

Erythema

Basis:

animal #1

Time point:

72 h

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 14 days

Results 32

Irritation parameter:

conjunctivae score

Remarks:

Erythema

Basis:

animal #2

Time point:

24 h

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 33

Irritation parameter:

conjunctivae score

Remarks:

Erythema

Basis:

animal #2

Time point:

48 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 34

Irritation parameter:

conjunctivae score

Remarks:

Erythema

Basis:

animal #2

Time point:

72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 35

Irritation parameter:

conjunctivae score

Remarks:

Erythema

Basis:

animal #3

Time point:

24 h

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 14 days

Results 36

Irritation parameter:

conjunctivae score

Remarks:

Erythema

Basis:

animal #3

Time point:

48 h

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 14 days

Results 37

Irritation parameter:

conjunctivae score

Remarks:

Erythema

Basis:

animal #3

Time point:

72 h

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 14 days

Results 38

Irritation parameter:

conjunctivae score

Remarks:

Erythema

Basis:

animal #4

Time point:

24 h

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 14 days

Results 39

Irritation parameter:

conjunctivae score

Remarks:

Erythema

Basis:

animal #4

Time point:

48 h

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 14 days

Results 40

Irritation parameter:

cornea opacity score

Remarks:

Erythema

Basis:

animal #4

Time point:

72 h

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 14 days

Results 41

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 14 days

Results 42

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

48 h

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 14 days

Results 43

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 14 days

Results 44

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 45

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

48 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 46

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 47

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 14 days

Results 48

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

48 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 14 days

Results 49

Irritation parameter:

chemosis score

Basis:

animal #4

Time point:

24 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 14 days

Results 50

Irritation parameter:

chemosis score

Basis:

animal #4

Time point:

48 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 14 days

Results 51

Irritation parameter:

chemosis score

Basis:

animal #4

Time point:

72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 14 days

Irritant / corrosive response data:

At the 1 hour reading slight reactions were observed in the cornea and well defined reactions of the coujunctiva (chemosis, redness and discharge) in all the rabbits. The iris were not affected in any of the rabbits. At the 24 hour reading the reactions of conjucntiva had slightly aggravated and the reactions of conjunctiva were unchanged. At the following 48 and 72 hour readings slight to well defined reactions were observed in the cornea and slight to moderate reactions were observed in the conjunctiva. A slight reaction was observed in the iris of one rabbit at the 48 hour readiug. On day 7 slight reactions were observed in the cornea of all the rabbits and slight reactions were observed in the conjunctiva of three rabbits. In one rabbit the conjunctiva appeared normal.
On day 14, the eyes of all 4 rabbits appeared normal.

Other effects:

conjunctival discharge was seen in all aninals at up to 72 hours.

Any other information on results incl. tables

On day 14 the eyes of all rabbits apppeared normal. It was therefore concluded that the eye changes induced by the treatment were reversible, and the study was terminated.

Individual irritation scores

Observation		1h	24h	48h	72h	Mean (24-72h)	7d	14d
Cornea	Opacity	2,1,1,1	2,2,2,2	2,1,2,2	2,1,1,2	1.75	1,1,1,1	0,0,0,0
Iris	Lesion	00,0,0,	0,0,0,0	0,0,0,1	0,0,0,0	0.08	0,0,0,0	0,0,0,0
Conjunctivae	Erythema	3,2,2,3	3,3,3,3	3,2,3,3	3,2,3,3	2.83	1,0,1,1	0,0,0,0
	Chemosis	2,2,2,3	3,2,2,2	3,2,2,2	2,1,2,2	2.08	1,0,1,1	0,0,0,0

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

It was concluded that the test substance CTF should be classified as an eye irritant (Category 2) under CLP.

Executive summary:

A study was performed by Scantox, Denmark, on behalf of Perstorp Polyols, Sweden (subcontracted through Toxicon AB, Sweden), to determine the potential for eye irritation of the test substance CTF. The study was conducted to GLP and according to OECD Test Guideline 405. The test substance was instilled in the eyes of four rabbits, and observations were taken shortly after exposure, and after 24, 48, and 72 hours, and 7 and 14 days. Slight to moderate reactions were seen at 24, 48, and 72 hours, slight reactions were observed at 7 days, and no reactions were seen at 14 days. It was concluded that the test substance CTF should be classified as irritating to eyes. On this basis, it can be concluded that CTF is assigned the symbol Xi and the risk-phrase R36 "Irritating to eyes" according to Directive 67/548/EEC. It is assigned the pictogram GHS07 with the signal word warning and the hazard statement H319 "causes serious eye irritation".