2,4,6,8-tetramethyl-1,3,5,7-tetraoxacyclooctane

Endpoint summary

Description of key information

Skin irritation in-vivo:

A study was carried according to OECD test method no. 404 to determine the primary skin irritation index and corrosive effects of the test item in the New Zealand White rabbit. A single 4-hour application of the test substance produced a primary irritation index of 0, the test item was therefore classified as a non-irritant to rabbit skin. No corrosive effects were noted.

Skin irritation in-vitro:

An in-vitro skin irritation test does not need to be conducted because adequate data from an in-vivo skin irritation study are available.

Eye irritation in-vivo:

A study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method used followed that described in the OECD No. 405. A single application of the test material to the non-irrigated eye of three rabbits produced transient iridial inflammation and minimal conjunctival irritation. All treated eyes appeared normal at the 48-hour observation. The test material produced a maximum group mean score of 11.0 and was classified .as a minimal irritant (Class 3 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system. However, the test material was classified as non-irritant according to the current GHS-criteria.

Eye irritation in-vitro:

An in-vitro eye irritation test does not need to be conducted because adequate data from an in-vivo eye irritation study are available.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

July 1983

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Specific details on test material used for the study:

- Name: P0071
- Physical appearance: Crystalline white solid
- Storage requirements: stored at ro.om temperature in the dark

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Santin and Kingman Ltd., The Field Station, Grimston, Aldbrough, Hull, Hull 4QE, UK
- Age at study initiation: young adults
- Weight at study initiation: 3.07-3.5 kg
- Housing: individual housing
- Diet (e.g. ad libitum): Standard Rabbit Diet, Special Diets Services Ltd., Stepfield, Witham, Essex, UK
- Water (e.g. ad libitum): tap water
- Acclimation period: 3 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22°C
- Humidity (%): 44-53%
- Photoperiod (hrs dark / hrs light): 14h artificial light & 10h darkness

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

yes, concurrent no treatment

Amount / concentration applied:

500 mg

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48 and 72 hours after treatment

Number of animals:

3 young adult females

Details on study design:

TEST SITE
- Area of exposure: ca. 6 cm2
- Type of wrap if used: ghauze patch, secured with impermeable adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) : 1, 24, 48 and 72 hours

SCORING SYSTEM:
- Method of calculation: Draize

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No abnormal skin reactions were noted on any treated site during the observation period. A primary irritation index of 0 was obtained. The test item was regarded as non-irritant to rabbit skin. No corrosive effects were noted.

Other effects:

None

Interpretation of results:

GHS criteria not met

Conclusions:

The substance was found to be non-irritating to rabbit skin.

Executive summary:

A study was carried according to OECD test method no. 404 to determine the primary skin irritation index and corrosive effects of the test item in the New Zealand White rabbit. A single 4-hour application of the test substance produced a primary irritation index of 0, the test item was therefore classified as a non-irritant to rabbit skin. No corrosive effects were noted.

Reference 2

Endpoint:

skin irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

April - May 1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

- Description: White powder
- Name: P0071
- Storage requirements: approx.. 4°C in the refrigerator

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Rosemead Rabbits, Waltham Abbey, Essex, U.K.
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.71-2.98 kg
- Housing: individual housing
- Diet (e.g. ad libitum): Rabbit Diet, Preston Farmers Limited, New Leake, Boston, Lincolnshire, U.K.
- Water (e.g. ad libitum): tap water
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-19°C
- Humidity (%): 43-47%
- Air changes (per hr): 15 changes/h
- Photoperiod (hrs dark / hrs light): 12h light / 12h darkness

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 ml test material

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

1 hour and 24, 48 and 72 hours following treatment

Duration of post- treatment incubation (in vitro):

not applicable; in-vivo test

Number of animals or in vitro replicates:

3 animals

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
- Time after start of exposure: n/a

SCORING SYSTEM:
- modified version of the system described by Kay J.H. and Calandra J.C., J. Soc. Cosmet. Chem., 1962,13, p 281-289

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

1

Reversibility:

fully reversible within: 24h

Remarks on result:

probability of mild irritation

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 48h

Remarks on result:

probability of mild irritation

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

A single application of the test material to the non-irrigated eye of three rabbits produced transient iridial inflammation and minimal conjunctival irritation. All treated eyes appeared normal at the 48-hour observation.The test material produced a maximum group mean score of 11.0 and was classified as a minimal irritant (Class 3 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system. However, GHS-criteria for classification are not met.

Interpretation of results:

GHS criteria not met

Conclusions:

The test item was found to be non-irritating to rabbit eyes.

Executive summary:

A study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method used followed that described in the OECD No. 405. A single application of the test material to the non-irrigated eye of three rabbits produced transient iridial inflammation and minimal conjunctival irritation. All treated eyes appeared normal at the 48-hour observation. The test material produced a maximum group mean score of 11.0 and was classified .as a minimal irritant (Class 3 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system. However, the test material was classified as non-irritant according to the current GHS-criteria.

Reference 2

Endpoint:

eye irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Guideline-studies; Klimisch 1

Justification for classification or non-classification

Based on the data available the substance is not classified or labeled according to Regulation 1272/2008/EC (CLP).