2-(methylamino)ethanol, compound with sulphur dioxide

Endpoint summary

Description of key information

2-(Methylamino)ethanol, compound with Sulfur dioxide, is no skin irritant and no eye irritant based on reliable in vivo study results available for the target chemical. Data for the analogues (cation(aq)/anion(aq)) are presented as supporting information but not considered to be directly transferable.

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable non-GLP study, comparable to guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

not applicable

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Principles of method if other than guideline:

Before OECD Guideline 404 was first adopted in 1981, skin irritation was tested using a BASF test.
The methods were based on Draize (Federal Register 38, No. 187, § 1500.41, p. 27019 (1973-09-27)).

GLP compliance:

no

Species:

rabbit

Strain:

other: albino (no further specification provided)

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: adult (based on body weight)
- Weight at study initiation: 3-4 kg
- Housing: stainless steel cage without bedding material
- Diet: standard pelleted feed for rabbits, ad libitum
- Water: ad libitum
- Acclimation period: more than 3 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 1 °C
- Humidity: 55 ± 10 %
- Photoperiod: 12 hours dark / 12 hours light

Type of coverage:

occlusive

Preparation of test site:

other: intact and abraded

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin served as negative control site

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 mL

Duration of treatment / exposure:

24 hours

Observation period:

7 days

Number of animals:

6 rabbits

Details on study design:

TEST SITE
- Area of exposure: on upper third of the back (2.5 × 2.5 cm²), intact skin: right side, abraded skin: left side
- Type of wrap if used: gauze (double layer) with elastic dressing, wrapped in PVC foil

SCORING SYSTEM:
Scoring was performed according to Draize (1959). The skin reactions were scored after 24 and 72 hours and after 7 days.
An irritation index was calculated by dividing the sum of the group mean scores for erythema and edema by the number of readings.
The derived irritation index was evaluated as follows:
Index intervals 0 -0.5: no irritant, 0.6 -3.0: weak irritant, 3.1 -5.0: moderate irritant, 5.1 -8.0: strong irritant.

Irritation parameter:

erythema score

Remarks:

(24-hour exposure)

Basis:

mean

Remarks:

(animal #1)

Time point:

other: 24/72 hours

Score:

0.5

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: tested on intact skin

Irritation parameter:

erythema score

Remarks:

(24-hour exposure)

Basis:

mean

Remarks:

(animal #2)

Time point:

other: 24/72 hours

Score:

0

Max. score:

4

Remarks on result:

other: tested on intact skin

Irritation parameter:

erythema score

Remarks:

(24-hour exposure)

Basis:

mean

Remarks:

(animal #3)

Time point:

other: 24/72 hours

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: tested on intact skin

Irritation parameter:

erythema score

Remarks:

(24-hour exposure)

Basis:

mean

Remarks:

(animal #4)

Time point:

other: 24/72 hours

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: tested on intact skin

Irritation parameter:

erythema score

Remarks:

(24-hour exposure)

Basis:

mean

Remarks:

(animal #5)

Time point:

other: 24/72 hours

Score:

0

Max. score:

4

Remarks on result:

other: tested on intact skin

Irritation parameter:

erythema score

Remarks:

(24-hour exposure)

Basis:

mean

Remarks:

(animal #6)

Time point:

other: 24/72 hours

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: tested on intact skin

Irritation parameter:

edema score

Remarks:

(24-hour exposure)

Basis:

mean

Remarks:

(all animals)

Time point:

other: 24/72 hours

Score:

0

Max. score:

4

Remarks on result:

other: tested on intact skin

Irritant / corrosive response data:

Test on intact skin, 24-hour application (key information):
The key results are summarised in the irritation/corrosion results table (see above).
The mean erythema score was ≤ 1 in 6/6 rabbits. No erythema (24/72 hours) was seen in 2/6 rabbits. Findings were fully reversibe in the remaining 4/6 rabbits within the observation period of 7 days.
There were no edema (24/72 hours).

Test on abraded (scarified skin), 24-hour application (supporting information):
The mean erythema score (24/72 hours) was 1 in 1/6 rabbits and 1.5 in the remaining 5/6 rabbits. At the 72-hour reading, slightly hardened scarified skin was observed in 3/6 rabbits. After 7 days, there was sore at the application site of 4/6 rabbits.
No edema were seen in 2/6 rabbits (24/72 hours). The mean edema score (24/72 hours) was 0.5 and 1 in each 1/6 rabbits and 1.5 in the remaining 2/6 rabbits.

Other effects:

At study termination, macroscopic examination of the application sites (intact and scarified skin) revealed no lesions of the hypodermal connective tissues and/or the subjacent musculature.

A primary irritation score of 1.38 was calculated (under consideration of the test results for intact plus abraded skin ). The test item was considered to be a weak irritant based on this score.

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable non-GLP study, comparable to guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

not applicable

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Principles of method if other than guideline:

Before OECD Guideline 405 was first adopted in 1981, eye irritation was tested using a BASF test.
The methods were based on Draize (Federal Register 38, No. 187, § 1500.42, p. 27019 (1973-09-27)).

GLP compliance:

no

Species:

rabbit

Strain:

other: albino (no further specification provided)

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Age at study initiation: adult (based on body weight)
- Weight at study initiation: 3-4 kg
- Housing: stainless steel cage without bedding material
- Diet: standard pelleted feed for rabbits, ad libitum
- Water: ad libitum
- Acclimation period: more than 3 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 1 °C
- Humidity: 55 ± 10 %
- Photoperiod: 12 hours dark / 12 hours light

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye served as negative control

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 mL

Duration of treatment / exposure:

single treatment

Observation period (in vivo):

72 hours after application; the study was terminated after the 72-hour reading

Number of animals or in vitro replicates:

6 rabbits

Details on study design:

SCORING SYSTEM:
Draize scoring system
Based on the Draize scores, a primary irritation index was calculated (max. score: 110)
The derived irritation index was evaluated as follows:
Index intervals 0 -10: no irritant, 11 -25: weak irritant, 26 -56: moderate irritant, 57 -110: strong irritant.

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

(animals #1-6)

Time point:

other: 24/48/72 hours

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

mean

Remarks:

(animals #1-6)

Time point:

other: 24/48/72 hours

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

(animal #1)

Time point:

other: 24/48/72 hours

Score:

0

Max. score:

3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

(animal #2)

Time point:

other: 24/48/72 hours

Score:

0

Max. score:

3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

(animal #3)

Time point:

other: 24/48/72 hours

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: scores: 1/0/0

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

(animal #4)

Time point:

other: 24/48/72 hours

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: scores: 1/0/0

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

(animal #5)

Time point:

other: 24/48/72 hours

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: scores: 1/0/0

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

(animal #6)

Time point:

other: 24/48/72 hours

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: scores: 1/0/0

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

(animals #1-6)

Time point:

other: 24/48/72 hours

Score:

0

Max. score:

4

Irritant / corrosive response data:

Slight conjunctival redness was the only test substance-related finding. This transient finding was noted at the 1-hour and 24-hour readings in 6/6 and 4/6 rabbits, respectively. The mean score (24/48/72 hours) for conjunctival redness was 0 in 2/6 rabbits and 0.3 in the remaining 4/6 rabbits.
The primary irritation index was calculated to be 0.44. The test substance was no irritant to the rabbit eye.

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation / corrosion

In a primary skin irritation study (BASF AG, 1979; 77/938), albino rabbits were dermally exposed to 0.5 mL of undiluted Kauraminhärter CE 5162 flüssig, i.e. 2 -(Methylamino)ethanol, compound with Sulfur dioxide, for 24 hours using intact skin (key information) or abraded skin (supporting information). Irritation was scored at 24 and 72 hours. The animals were observed for 7 days. In the key study, i.e. after 24 -hour exposure of intact skin, the mean erythema score (24/72 hours) was below or equal to 1 in 6/6 rabbits. No erythema (24/72 hours) was seen in 2/6 rabbits. Findings were fully reversibe in the remaining 4/6 rabbits within the observation period of 7 days. There were no edema (24/72 hours). Under the conditions of this study, and in view of the long exposure duration of 24 hours in association with the use of occlusive dressings, the test substance was considered to be no skin irritant.

A direct read-across assessment is not considered applicable for the endpoint skin irritation/corrosion. In supporting studies in Vienna White rabbits conducted by means of the same method (similar to OECD 404) with 2 -(Methylamino)ethanol, the test substance revealed corrosive properties (BASF AG, 1981; 79/561 and BASF AG 1965; XV126) that were considered to be at least in part attributable to alkaline properties. As evidenced by reliable supporting data the source chemical Sodium sulfite (BASF AG, 1981; 81/311) showed no skin irritating/corrosive properties. No data are available for Disodium disulfite; however, it can reasonably be expected to show the same properties as Sodium sulfite, i.e. to be no skin irritant.

Eye irritation

In a primary eye irritation study (BASF AG, 1979; 77/938), 100 µL of undiluted Kauraminhärter CE 5162 flüssig, i.e. 2 -(Methylamino)ethanol, compound with Sulfur dioxide, was instilled into the conjunctival sac of each one eye of 6 albino rabbits. Irritation was scored by the method of Draize at 1, 24, 48 and 72 hour(s). Slight conjunctival redness was the only test substance-related finding noted. The mean score (24/48/72 hours) for conjunctival redness was 0 in 2/6 rabbits and 0.3 in the remaining 4/6 rabbits. Under the conditions of this study, the test substance was no eye irritant.

A direct read-across assessment is not considered applicable for the endpoint eye irritation. Supporting study data indicated that both 2 -(Methylamino)ethanol (BASF AG, 1965; XV126) and Disodium disulfite (BASF AG, 1984; 84/200) have the potential to damage rabbit eyes seriously and irreversibly. This finding is considered largely related to acid/alkaline properties of these substances and thus not applicable for 2 -(Methylamino)ethanol, compound with Sulfur dioxide, as evidenced by the key study results.

Respiratory irritation

No experimental data are available on respiratory irritation.

Justification for selection of skin irritation / corrosion endpoint:
The key study was selected for the assessment of the skin irritation/corrosion hazard since it provides reliable data on the target chemical.

Justification for selection of eye irritation endpoint:
The key study was selected for the assessment of the eye irritation hazard since it provides reliable data on the target chemical.

Justification for classification or non-classification

The key study results obtained for the test substance 2 -(Methylamino)ethanol, compound with Sulfur dioxide, in reliable in vivo studies are relevant for classification. Based on these studies, 2-(Methylamino)ethanol, compound with Sulfur dioxide, is not subject to classification for irritation/corrosion according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (GHS/CLP).