1-(2,6-bis(4-tolyl)-1,3-dioxano(5,4-d)-1,3-dioxan-4-yl)ethane-1,2-diol

Endpoint summary

Description of key information

Skin irritation: No skin irritation was observed in animal.
Eye irritation: Minor redness was observed but was fully reversible within 24 hours. 

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1988-03-17 to 1988-03-24

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study was carried out to generally valid and internally-accepted guidelines and performed according to GLP.

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Gorseside Rabbits, Northchurch, Berkhamstead, Hertfordshire
- Age at study initiation: 12 weeks
- Weight at study initiation: approx 2.0 kg
- Housing: Individually housed in grid-bottomed metal cages.
- Diet: SQC standard rabbit pellets produced by Special Diet Services, Witham, Essex, ad libitum (antibiotic free)
- Water: mains drinking water ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature: 17 to 20°C.
- Humidity: 44-77%.
- Air changes (per hr): No data
- Photoperiod: 12 hrs dark / 12 hrs light (fluorescent lighting)

IN-LIFE DATES: No data

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Remarks:

(distilled)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 g material mixed with 0.5 ml distilled water

VEHICLE
- distilled water

Duration of treatment / exposure:

4 hours

Observation period:

7 days (observations at 1 hr, 24 hr, 48 hr, 72 hr, 7 days)

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm × 2.5 cm
- Type of wrap if used: lint pad; held in place with 7.5 cm width elastic adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing: With cotton wool soaked in water warmed to approx. 37 °C.
- Time after start of exposure: 4 hours

SCORING SYSTEM:
Animals were examined under a standard light source designed to comply with the requirements of BS 950 Part 1 (Artificial Daylight for the assessment of colour) and irritation allocated a numerical value based on the following:

Erythema and Eschar formation:
0 - No erythema:
1 - Very slight erythema (barely perceptible)
2 - Well-defined erythema
3 - Moderate to severe erythema
4 - Severe erythema (beet redness) to slight eschar formation (injuries in depth)

Oedema formation:
0 - No oedema
1 - Very slight oedema (barely perceptible)
2 - Slight oedema (edges of area well defined by definite raising)
3 - Moderate oedema (raised approximately 1mm)
4 - Severe oedema (raised more than 1mm and extending beyond area of exposure)

Other signs of reaction to treatment such as systematic effects were recorded.

Irritation parameter:

erythema score

Basis:

animal: 769

Time point:

other: mean of scores at 24, 48 & 72 hr

Score:

0

Max. score:

4

Reversibility:

other: No irritation at any observation

Irritation parameter:

erythema score

Basis:

animal: 773

Time point:

other: mean of scores at 24, 48 & 72 hr

Score:

0

Max. score:

4

Reversibility:

other: No irritation at any observation

Irritation parameter:

erythema score

Basis:

animal: 774

Time point:

other: mean of scores at 24, 48 & 72 hr

Score:

0

Max. score:

4

Reversibility:

other: No irritation at any observation

Irritation parameter:

edema score

Basis:

animal: 769

Time point:

other: mean of scores at 24, 48 & 72 hr

Score:

0

Max. score:

4

Reversibility:

other: No irritation at any observation

Irritation parameter:

edema score

Basis:

animal: 773

Time point:

other: mean of scores at 24, 48 & 72 hr

Score:

0

Max. score:

4

Reversibility:

other: No irritation at any observation

Irritation parameter:

edema score

Basis:

animal: 774

Time point:

other: mean of scores at 24, 48 & 72 hr

Score:

0

Max. score:

4

Reversibility:

other: No irritation at any observation

Irritant / corrosive response data:

No irritation or corrosion to any test animal was recorded at any time.

Other effects:

No other local or systemic effects.

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

No irritation was apparent in any animal during the course of the study. It is concluded that Gel All MD is not an irritant to rabbit skin.

Executive summary:

The purpose of the study was to assess the skin irritation potential of Gel All MD in rabbits.

The method used was designed to meet the requirements of OECD Guideline No. 404.

Gel All MD, moistened with water, was applied for four hours under a semi-occlusive dressing to the clipped dorsal skin of three rabbits. Assessments for skin irritation were made 1, 24, 48 and 72 hours and 7 days after removal of the dressing.

No skin irritation was observed in animal animal at any assessment.

It was concluded that Gel All MD is not irritant to rabbit skin.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

21 March 1988 to 13 June 1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP Guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

(adopted 24 February 1987)

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Healthy female rabbits were obtained from Goreside Rabbits, Northchurch, Berkhamsted, Hereford
- Age at study initiation: At receipt the animals were 8 weeks of age, but left to acclimatise for at least 9 days.
- Weight at study initiation: See table.
- Housing: The rabbits were individually housed in grid-bottomed metal cages.
- Diet (e.g. ad libitum): A commercially available antibiotic free rabbit diet (SQC standard rabbit pellets produced by Special Diet Services, Witham, Essex), ad libitum.
- Water (e.g. ad libitum): Mains drinking water via an automatic nozzle, ad libitum.
- Acclimation period: At least 9 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 20°C
- Humidity (%): Relative humidity within the range 44 - 77%.
- Photoperiod (hrs dark / hrs light): Fluorescent lighting was controlled to give an artificial cycle of 12 hours light/12 hours dark per day.

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 mL of the supplied material (weighing approximately 30 mg)

Duration of treatment / exposure:

Single exposure with observation for 7 days

Observation period (in vivo):

One, 24, 48 and 72 hours and 7 days following instillation of the test material the animals eyes were examined macroscopically under a standard light source.

Number of animals or in vitro replicates:

3

Details on study design:

One restrained rabbit was dosed initially to assess the severity of any irritant response. As no marked irritation was seen a further two restrained animals were dosed, bringing the group size to three.

The test material was instilled into the right eye of each restrained animal by gently pulling away the lower lid from the eyeball to form a cup into which the test material was placed. The lids were then held shut for a few seconds. The treated eyes of the rabbits were not rinsed after dosing. The left eye was untreated and served as a control.

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #1

Remarks:

(No 781)

Time point:

other: mean of scores at 24, 48 and 72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible within: 24 hours

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #2

Remarks:

(No 777)

Time point:

other: mean of scores at 24, 48 and 72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #3

Remarks:

(No 778)

Time point:

other: mean of scores at 24, 48 and 72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

(No 781)

Time point:

other: mean of scores at 24, 48 and 72 h

Score:

0

Max. score:

4

Remarks on result:

other: No chemosis observed at any observation

Irritation parameter:

chemosis score

Basis:

animal #2

Remarks:

(No 777)

Time point:

other: mean of scores at 24, 48 and 72 h

Score:

0

Max. score:

4

Remarks on result:

other: No chemosis observed at any observation

Irritation parameter:

chemosis score

Basis:

animal #3

Remarks:

(No 778)

Time point:

other: mean of scores at 24, 48 and 72 h

Score:

0

Max. score:

4

Remarks on result:

other: No chemosis observed at any observation

Irritation parameter:

cornea opacity score

Basis:

animal #1

Remarks:

(No 781)

Time point:

other: mean of scores at 24, 48 and 72 h

Score:

0

Max. score:

4

Remarks on result:

other: No cornea effects observed at any observation

Irritation parameter:

cornea opacity score

Basis:

animal #2

Remarks:

(No 777)

Time point:

other: mean of scores at 24, 48 and 72 h

Score:

0

Max. score:

4

Remarks on result:

other: No cornea effects observed at any observation

Irritation parameter:

cornea opacity score

Basis:

animal #3

Remarks:

(No 778)

Time point:

other: mean of scores at 24, 48 and 72 h

Score:

0

Max. score:

4

Remarks on result:

other: No cornea effects observed at any observation

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

(No 781)

Time point:

other: mean of scores at 24, 48 and 72 h

Score:

0

Max. score:

2

Remarks on result:

other: No iris effects observed at any observation

Irritation parameter:

iris score

Basis:

animal #2

Remarks:

(No 777)

Time point:

other: mean of scores at 24, 48 and 72 h

Score:

0

Max. score:

2

Remarks on result:

other: No iris effects observed at any observation

Irritation parameter:

iris score

Basis:

animal #3

Remarks:

(No 778)

Time point:

other: mean of scores at 24, 48 and 72 h

Score:

0

Max. score:

2

Remarks on result:

other: No iris effects observed at any observation

Irritant / corrosive response data:

One hour after instillation, well defined conjunctival redness was seen in two rabbits and slight redness in the third animal. Only slight conjunctival redness was seen after 24 hours in two animals. All eyes were normal within 48 hours.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Slight to moderate conjunctival irritancy (redness) was observed up to 24 hours post-installation.

Executive summary:

The purpose of the study was to assess the eye irritation potential of Gel All MD in rabbits.

The method used was designed to meet the requirements of OECD Guideline No. 405.

Gel All MD was instilled into the right eye of three rabbits. Assessments of eye irritation were made 1, 24, 48 and 72 hours and 7 days after installation.

One hour after instillation, well defined conjunctival redness was seen in two rabbits and slight redness in the third animal. Only slight conjunctival redness was seen after 24 hours in two animals. All eyes were normal within 48 hours. No chemosis, iridial irritation or cornea effects were observed.

The slight irritation (redness) was fully reversible and not sufficient for classification.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin Irritation:

The purpose of the study was to assess the skin irritation potential of Gel All MD in rabbits.

The method used was designed to meet the requirements of OECD Guideline No. 404.

Gel All MD, moistened with water, was applied for four hours under a semi-occlusive dressing to the clipped dorsal skin of three rabbits. Assessments for skin irritation were made 1, 24, 48 and 72 hours and 7 days after removal of the dressing.

No skin irritation was observed in animal at any assessment.

It was concluded that Gel All MD is not irritant to rabbit skin.

Eye Irritation:

The purpose of the study was to assess the eye irritation potential of Gel All MD in rabbits.

The method used was designed to meet the requirements of OECD Guideline No. 405.

Gel All MD was instilled into the right eye of three rabbits. Assessments of eye irritation were made 1, 24, 48 and 72 hours and 7 days after installation.

One hour after instillation, well defined conjunctival redness was seen in two rabbits and slight redness in the third animal. Only slight conjunctival redness was seen after 24 hours in two animals. All eyes were normal within 48 hours. No chemosis, iridial irritation or cornea effects were observed.

The slight irritation (redness) was fully reversible and not sufficient for classification.

Justification for classification or non-classification

The results from skin irritation and eye irritation studies were evaluated according to the Classification, Labelling and Packaging Regulation (EC) 1272/2008 (CLP).

Skin irritation:

No skin irritation was caused by a single 4 hours exposure to the substance. Based on these results, the substance does not have to be classified as a skin irritant as it does not meet the criteria for classification according to the Classification, Labelling and Packaging Regulation (CLP).

Eye Irritation:

The substance did not meet the criteria for classification as an eye irritant according to CLP based on the mean scores obtained for each animal for corneal opacity (0 for all animals), iritis (0 for all animals), conjunctival redness (0.3 for 2 animals) and chemosis (0 for all animals), as these were below the threshold for classification. All irritation effects (redness) were fully reversible within 48 hours. Therefore the substance is not classified as an eye irritant.