Dodecyl(2-hydroxy-3-sulphonatopropyl)dimethylammonium

Endpoint summary

Description of key information

An in vivo skin irritation study and an in vivo eye irritation study are available.

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:

25 May 1995 to 31 July 1995

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

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Specific details on test material used for the study:

Betadet S-20
Lot number: 7244
Appearance: transparent viscous liquid
pH: 7.49
Stored: Room temperature, protected from light.

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Three New Zealand White male rabbits were used.
Weight on receipt: 2.1-2.2 kg
Age on receipt: approximately 9-11 weeks
Source: Accredited supplier
Housing: Individually in stainless steel cages with a grill floor
Acclimatisation period: at least seven days
Weight at administration of test substance: 2.3-2.8 kg
Temperature: 17-22 degrees C
Humidity: 50-90%
Photoperiod: 12 dark/light cycle
Diet: Standard rabbit diet UAR 112, supplied by PANLAB, S. L., ad libitum
Water: Supplied by Compañia de Aguas de Sabadell, ad libitum

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

Four hours

Observation period:

The reaction of the test zone was evaluated approximately 30-60 minutes and 24, 48 and 72 hours after the end of the exposure period. Additional observations were carried out after seven days to check the reversibility of the observed reactions.

Number of animals:

Three

Details on study design:

Animals were shaved approximately 24 hours before administration using an electric razor, leaving the back and sides exposed from the scapula to the pelvis.

One square test zone, measuring approximately 6 square centimetres was delimited on the shaved intact skin of one side of the animals.

The test substance was applied in a single dose of 0.5 mL. The substance was placed on 2.5 x 2.5 cm squares of hydrophilic gauze and applied to the corresponding test area. The resulting patches were held in place with strips of adhesive tape. A strip of gauze was wrapped around the trunk of the animals using adhesive tape to hold the patches in place.

The animals were observed following administration before being returned to their cages.

After a 4-hour period, the patches were removed and the remainder of the product eliminated with water.

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.78

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Scores for irritation

	60 minutes	24 hours	48 hours	72 hours	Mean (24-72 hours)	7 days
Erythema	1,1,1	1,1,1	0,1,1	0,1,1	0.78	0,0,0
Oedema	0,0,0	0,0,0	0,0,0	0,0,0	0.00	0,0,0

Interpretation of results:

GHS criteria not met

Conclusions:

Minimal transient irritation was observed in this study; the substance does not require classification according to CLP criteria.

Executive summary:

A skin irritation study was conducted with Betadet S-20 according to OECD Test Guideline 404. The test material was applied to the skin of 3 rabbits (0.5 mL) for 4 hours. The animals were observed for 7 days. The treatment sites were assessed after 1, 24, 48 and 72 hours. The sites were assessed after 7 days to determine reversibility. One hour after patch removal, slight edema (Grade 1) was noted for all 3 animals. The mean effect scores over time of 24, 48 and 72 hours were 0.78 for erythema and 0.0 for oedema. The effects were fully reversible within 7 days. Minimal transient irritation was observed in this study; the substance does not require classification according to CLP criteria.

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:

25 May 1995 to 31 July 1995

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

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Specific details on test material used for the study:

Betadet S-20
Lot number: 7244
Appearance: transparent viscous liquid
pH: 7.49
Stored: Room temperature, protected from light.

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Three New Zealand White male rabbits were used.
Weight on receipt: 2.0-2.4 kg
Age on receipt: approximately 9-110 weeks
Source: B and K Universal G.J., S.L.
Housing: Individually in stainless steel cages with a grill floor
Acclimatisation period: at least seven days
Weight at administration of test substance: 2.2-2.6 kg
Temperature: 18-22 degrees C
Humidity: 50-85%
Photoperiod: 12 hour dark/light cycle
Diet: Standard rabbit diet UAR 112, supplied by PANLAB, S. L., ad libitum
Water: Supplied by Compañia de Aguas de Sabadell, ad libitum

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 mL of undiluted test susbtance.

Duration of treatment / exposure:

24 hours.

Observation period (in vivo):

21 days after treatment

Number of animals or in vitro replicates:

Three

Details on study design:

Following administration of the test substance, the eyelids were held closed for approximately 10 seconds. The behaviour of the animals was observed following instillation of the test substance. The animals were then returned to their cages.

The dree of eye irritation as evaluated for each rabbit at 1, 24, 48 and 72 hours after treatment. Additional observations were made on Days 7, 14 and 21 after treatment to check the reversibility of the reactions.

Observations were made after applying 2% aqueous sodium fluorescein to test the area and washing with physiological saline, with the exception of the 1 hour observations. Corneal alterations were made with the aid of a transilluminator with a cobalt blue filter.

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 21 days

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 7 days

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 21 days

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

1.22

Max. score:

4

Reversibility:

fully reversible within: 14 days

Other effects:

Behaviour and physical conditions of the rabbits were normal throughout the study.

One hour after administration, Betadet S-20 induced grade 2 redness in the palpebral conjunctivae of all the animals, accompanied by injected vessels in the bulbar conjunctivae and lacrimation. Swelling with partial inversion of the lids (grade 2) and congestion and injection of the iris (grade 1) was noted in all animals.

Eye irritation scores

	60 minutes	24 hours	48 hours	72 hours	Mean (24-72 hours)	7 days	14 days	21 days
Cornea	0,1,1	1,1,1	1,1,1	1,1,1	1.00	1,1,0	0,1,0	0,1,-
Iris	1,1,1	1,1,1	1,1,1	1,1,1	1.00	0,0,0	0,0,0	0,0,-
Erythema	2,2,2	2,2,2	2,2,2	2,2,2	2.00	1,1,1	1,1,0	0,0,-
Chemosis	2,2,2	1,2,1	1,2,1	1,1,1	1.22	1,1,1	0,0,0	0,0,-

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

Findings were reversible, with the exception of Grade 1 corneal opacity in one rabbit at 21 days.

Executive summary:

An eye irritation study was conducted with Betadet S-20 according to OECD Test Guideline 405. The test material was applied to the eyes of 3 rabbits (0.1 mL) for 24 hours. The animals were observed for 21 days. The corneal opacity, iris lesions, redness and chemosis were assessed after 1, 24, 48 and 72 hours post-treatment. Observations were also made on Days 7, 14 and 21 to check for reversibility. Signs of irritation were observed in all rabbits. Corneal opacity (Grade 1) was observed in all rabbits and persisted in one rabbit at study termination at Day 21. Iridial inflammation (Grade 1) was observed in all rabbits and was reversible by Day 7. Conjunctival erythema (Grade 2) was observed in all animals and was reversible by Day 21.

Conjunctival chemosis (Grade 2) was observed in all animals and was reversible by Day 14. The substance meets the CLP criteria for classification as a Category 2 eye irritant based on the mean (24 -72 hour) scores for corneal opacity, iridial inflammation and conjunctival erythema. However based on the finding of corneal opacity persisting to study termination in one rabbit, classification in CLP Category 1 is triggered.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation

A skin irritation study was conducted with Betadet S-20 according to OECD Test Guideline 404. The test material was applied to the skin of 3 rabbits (0.5 mL) for 4 hours. The animals were observed for 7 days. The treatment sites were assessed after 1, 24, 48 and 72 hours. The sites were assessed after 7 days to determine reversibility. One hour after patch removal, slight edema (Grade 1) was noted for all 3 animals. The mean effect scores over time of 24, 48 and 72 hours were 0.78 for erythema and 0.0 for oedema. The effects were fully reversible within 7 days. Minimal transient irritation was observed in this study; the substance does not require classification according to CLP criteria.

Eye irritation

An eye irritation study was conducted with Betadet S-20 according to OECD Test Guideline 405. The test material was applied to the eyes of 3 rabbits (0.1 mL) for 24 hours. The animals were observed for 21 days. The corneal opacity, iris lesions, redness and chemosis were assessed after 1, 24, 48 and 72 hours post-treatment. Observations were also made on Days 7, 14 and 21 to check for reversibility. Signs of irritation were observed in all rabbits. Corneal opacity (Grade 1) was observed in all rabbits and persisted in one rabbit at study termination at Day 21. Iridial inflammation (Grade 1) was observed in all rabbits and was reversible by Day 7. Conjunctival erythema (Grade 2) was observed in all animals and was reversible by Day 21.

Conjunctival chemosis (Grade 2) was observed in all animals and was reversible by Day 14. The substance meets the CLP criteria for classification as a Category 2 eye irritant based on the mean (24 -72 hour) scores for corneal opacity, iridial inflammation and conjunctival erythema. However based on the finding of corneal opacity persisting to study termination in one rabbit, classification in CLP Category 1 is triggered.

Justification for classification or non-classification

The substance requires classifcation as a Category 1 eye irritant under CLP. Classification as a skin irrtant is not required.