Reaction products of fatty acid chlorides, C8-12 (even numbered) with glycine and sodium hydroxide

Endpoint summary

Description of key information

The registration Substance Hostapon SLG is of low acute toxicity based on the read-across to Hostapon SG.

Hostapon SG (25% Sodium N-Cocoyl Glycinate) caused no effect at single oral application of 2000 mg/kg/day in acute oral toxicity study and and no significant toxic effect in 28 -day repeated dose toxicity study at 1000 mg/kg/day.

Hostapon SG (70% Sodium N-Cocoyl Glycinate) did not cause any effect at single dermal application (24h patch application) of 2000 mg/kg/day.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories
- Age at study initiation: 11 weeks
- Weight at study initiation: 178 - 200 g
- Fasting period before study: none, except overnight fasting period before dosing
- Housing: in groups of three in Makrolon type-4 cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 10 - 15 per hour
- Photoperiod (hrs dark / hrs light): light / dark cycle of 12 hours

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 0.2 g/mL
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: water

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg body weight


CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Limit dose

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

6 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical signs and mortality daily, body weighs on test days 1, 8 and 15
- Necropsy of survivors performed: yes

Statistics:

No

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occured during the study

Clinical signs:

other: No clinical signs observed during the study

Gross pathology:

No macroscopic findings were recorded at necropsy

Other findings:

none

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 of Hostapon SG after single oral administration to rats is greater than 2000 mg/kg body weight

Executive summary:

The commercial product Hostapon SG was investigated for its acute oral toxicity according to the OECD 423. Six female rats were treated per gavage at 2000 mg/kg bw. No effect was found. The LD50 > 2000 mg/kg bw was obtained.

Reference 2

Endpoint:

acute toxicity: oral

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Justification is provided in Chapter 13.

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories
- Age at study initiation: 11 weeks
- Weight at study initiation: 178 - 200 g
- Fasting period before study: none, except overnight fasting period before dosing
- Housing: in groups of three in Makrolon type-4 cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 10 - 15 per hour
- Photoperiod (hrs dark / hrs light): light / dark cycle of 12 hours

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 0.2 g/mL
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: water

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg body weight


CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Limit dose

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

6 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical signs and mortality daily, body weighs on test days 1, 8 and 15
- Necropsy of survivors performed: yes

Statistics:

No

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occured during the study

Clinical signs:

other: No clinical signs observed during the study

Gross pathology:

No macroscopic findings were recorded at necropsy

Other findings:

none

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 > 2000 mg/kg bw

Executive summary:

The acute oral toxicity of the Hostapon SLG was evaluated based on the read-across approach using the acute oral toxicity data for Hostapon SG.

The commercial product Hostapon SG (25% of sodium N-cocoyl glycinate) was investigated for its acute oral toxicity according to the OECD 423. Six female rats were treated per gavage at 2000 mg/kg bw. No effect was found. The LD50 > 2000 mg/kg bw was obtained.

Likewise, no concern can be derived for the commercial product Hostapon SLG.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Acute toxicity: via dermal route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2010-08-24 to 2010-11-04

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Test Animals:
Animals: Rat, RccHan: WIST(SPF)
Rationale: Recognized by international guidelines as a recommended test system.
Breeder: Harlan Laboratories B.V., Kreuzelweg 53, 5961 NM / The Netherlands
Number of Animals per Group: 5 males and 5 females
Total Number of Animals: 5 males and 5 females
Age (when treated): Males: 9 weeks, Females: 11 weeks
Body Weight Range (when treated): 228 g – 253 g (males), 189 g – 207 g (females)
Identification: Unique cage number and corresponding color-coded spots on the tail. The animals were marked during acclimatization.
Randomization: Selected by hand at time of delivery. No computer generated randomization program.
Acclimatization: Eight days under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.

Environmental Conditions:
Conditions: Standard Laboratory Conditions. Air-conditioned with 10-15 air changes per hour, and continuously monitored environment with ranges for room temperature 22 ± 3 °C and for relative humidity between 30-70%, automatically controlled light cycle of 12 hours light and 12 hours dark, music during the daytime light period.
Accommodation: During acclimatization in groups of five per sex in Makrolon type-4 cages with standard softwood bedding. Individually in Makrolon type-3 cages with standard softwood bedding (‘Lignocel’ J. Rettenmaier&Söhne GmbH&CoKG, 73494 Rosenberg / Germany, imported by Provimi Kliba AG, 4303 Kaiseraugst / Switzerland) during treatment and observation. Paper enrichment, Reference no. 207057, batch no. 67, (Enviro-dri from Lillico, Biotechnology, Surrey / UK) was included.
Diet: Pelleted standard Teklad Rat-Mouse Diet 2914C, irradiated, batch no. 30/10 (Provimi Kliba AG, 4303 Kaiseraugst / Switzerland) ad libitum. Results of analyses for contaminants are archived at Harlan Laboratories Ltd.
Water: Community tap water from Füllinsdorf ad libitum. Results of bacteriological, chemical and contaminant analyses are archived at Harlan Laboratories Ltd.

Type of coverage:

semiocclusive

Vehicle:

polyethylene glycol

Details on dermal exposure:

Preparation of Dose Formulations:
Dose levels are in terms of the test item as supplied by the Sponsor. The test item was weighed into a tared glass beaker on a suitable precision balance and the vehicle added (weight:volume). The formulation was prepared shortly before the application using a magnetic stirrer, a spatula and an Ultra-Turrax as homogenizers. Homogeneity of the test item in the vehicle was maintained during administration using a magnetic stirrer.

Test Item Administration:
One day before treatment, the backs of the animals were clipped with an electric clipper, exposing an area of approximately 10% of the total body surface. Only those animals without injury or irritation on the skin were used in the test. On test day 1, the test item was applied evenly on the intact skin with a syringe and covered with a surgical gauze pad (ca. 5 x 5 cm) held in contact with the skin by means of an adhesive hypoallergenic aerated semi-occlusive dressing and an elastic adhesive restrainer bandage wrapped around the abdomen.
The application volume was 6 mL/kg.
Twenty-four hours after the application the dressing was removed and the skin was flushed with lukewarm tap water and drapped off with disposable paper towels. Thereafter, the reaction sites were assessed. All animals were re-shaved on test day 8 to facilitate the reading of the local reactions.
Rationale: Dermal administration was used as this is one possible route of human exposure during manufacture, handling and use of the test item.

Duration of exposure:

24 hours

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

5 males and 5 females

Control animals:

not required

Details on study design:

Purpose:
The purpose of this study was to assess the acute dermal toxicity of Hostapon SG dried when administered to rats by single semi-occlusive dermal application, followed by an observation period of 14 days. This study should provide a rational basis for risk assessment.

Vehicle:
The vehicle was chosen after a non-GLP solubility trial which was performed before the study initiation date. Therefore, solubility testing was excluded from the statement of compliance. According to the Sponsor, the test item is soluble in water up to a concentration of 25%. Therefore, polyethylene glycol 300 (PEG 300) was used as vehicle and the test item could be dispersed at the technically highest concentration of 33 % (w/w). This was achieved with an Ultra Turrax and resulted in a white liquid, which was considered dermally applicable.
The following information was provided by Harlan Laboratories Ltd.:
Identification: Polyethylene glycol 300 (PEG 300)
Description: Colorless viscous liquid
Lot Number: STBB 3451
Source: Sigma-Aldrich Chemie GmbH, Riedstr. 2, D-89555 / Germany
Stability of the Vehicle: Stable under storage conditions
Expiry Date: 30-Apr-2012
Storage Conditions: At room temperature (range of 20 ± 5 °C), light protected.
Safety Precautions: Routine hygienic procedures were used to ensure the health and safety of the personnel.

Observations:
Viability / Mortality: Daily during the acclimatization period. Once before treatment, within the first 30 minutes and at approximately 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during days 2-15.
Clinical Signs: Daily during the acclimatization period. Once before treatment, within the first 30 minutes and at approximately 1, 2, 3 and 5 hours after administration on test day 1. Once daily during days 2-15. All abnormalities will be recorded.
Local Dermal Signs: Once daily during days 2 (following dressing removal) through day 15 using the numerical scoring system described in Appendix I.
Body Weights: On test days 1 (prior to administration), 8 and 15.

Pathology:
Necropsy: All animals were sacrificed at the end of the observation period by carbon dioxide asphyxiation and discarded after macroscopic examinations were performed. An external examination and opening of the abdominal and thoracic cavities for examinations of major organs was performed. The appearance of any macroscopic abnormalities was recorded. No organs or tissues were retained.

Data Compilation:
Viability/mortality was recorded on data sheets.
Body weights were recorded on-line with the ToxControl Computer System.
Clinical signs, local dermal signs, mortality data and macroscopic findings were compiled into the ToxControl Computer System during recording.
The ToxControl Computer System has been licenced for Harlan Laboratories Ltd. and validated with respect to data collection, storage and retrievability.

Statistics:

No statistical analysis was used.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No intercurrent deaths occurred during the course of the study.

Clinical signs:

other: No clinical signs were recorded throughout the entire observation period.

Gross pathology:

No macroscopic findings were recorded at necropsy.

Local dermal signs:

Very slight to slight erythema was observed on test day 2 (1 male) or from test day 2 to test day 4 (1 female) or test day 6 (1 male). Very slight to slight oedema and slightly maculated crusts were observed in one female (No. 10) from test day 2 to 3 or from test day 7 to 15, the end of the observation period. Slight desquamation was noted in one male and three females during test day 3 to test day 7 or 11 and in one male from test day 8 to test day 12. Slight to moderate desquamation was noted in one female from test day 3 to test day 14. The test item caused white to yellow discoloration of the treated skin in two males and one female on test day 2.

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 of Hostapon SG (70% sodium N-cocoyl glycinate) after single dermal administration to rats is greater than 2000 mg/kg body weight

Executive summary:

The acute dermal toxicity of Hostapon SG (70% sodium N-cocoyl glycinate) was investigated in an OECD 402 study in accordance with the principles of GLP. Five male and five female Wistar rats were treated with the test substance at 2000 mg/kg by dermal application. The test item was formulated in polyethylene glycol 300 as vehicle. The application period was 24 hours. Following a 14 day observation period all animals were necropsied and examined macroscopically. No intercurrent deaths occurred and no clinical signs were recorded throughout the entire observation period. The only substance related effects consisted of very slight to slight dermal irritation reactions in form of erythema and/or oedema in one male and two females during the observation period. No macroscopic findings were observed at necropsy. Based on the study results the median lethal dose (LD50) of Hostapon SG (70% sodium N-cocoyl glycinate) after single dermal administration to rats of both sexes was greater than 2000 mg/kg body weight.

Reference 2

Endpoint:

acute toxicity: dermal

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

2010-08-24 to 2010-11-04

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.

Justification for type of information:

Justification is provided in Chapter 13.

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Test Animals:
Animals: Rat, RccHan: WIST(SPF)
Rationale: Recognized by international guidelines as a recommended test system.
Breeder: Harlan Laboratories B.V., Kreuzelweg 53, 5961 NM / The Netherlands
Number of Animals per Group: 5 males and 5 females
Total Number of Animals: 5 males and 5 females
Age (when treated): Males: 9 weeks, Females: 11 weeks
Body Weight Range (when treated): 228 g – 253 g (males), 189 g – 207 g (females)
Identification: Unique cage number and corresponding color-coded spots on the tail. The animals were marked during acclimatization.
Randomization: Selected by hand at time of delivery. No computer generated randomization program.
Acclimatization: Eight days under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.

Environmental Conditions:
Conditions: Standard Laboratory Conditions. Air-conditioned with 10-15 air changes per hour, and continuously monitored environment with ranges for room temperature 22 ± 3 °C and for relative humidity between 30-70%, automatically controlled light cycle of 12 hours light and 12 hours dark, music during the daytime light period.
Accommodation: During acclimatization in groups of five per sex in Makrolon type-4 cages with standard softwood bedding. Individually in Makrolon type-3 cages with standard softwood bedding (‘Lignocel’ J. Rettenmaier&Söhne GmbH&CoKG, 73494 Rosenberg / Germany, imported by Provimi Kliba AG, 4303 Kaiseraugst / Switzerland) during treatment and observation. Paper enrichment, Reference no. 207057, batch no. 67, (Enviro-dri from Lillico, Biotechnology, Surrey / UK) was included.
Diet: Pelleted standard Teklad Rat-Mouse Diet 2914C, irradiated, batch no. 30/10 (Provimi Kliba AG, 4303 Kaiseraugst / Switzerland) ad libitum. Results of analyses for contaminants are archived at Harlan Laboratories Ltd.
Water: Community tap water from Füllinsdorf ad libitum. Results of bacteriological, chemical and contaminant analyses are archived at Harlan Laboratories Ltd.

Type of coverage:

semiocclusive

Vehicle:

polyethylene glycol

Details on dermal exposure:

Preparation of Dose Formulations:
Dose levels are in terms of the test item as supplied by the Sponsor. The test item was weighed into a tared glass beaker on a suitable precision balance and the vehicle added (weight:volume). The formulation was prepared shortly before the application using a magnetic stirrer, a spatula and an Ultra-Turrax as homogenizers. Homogeneity of the test item in the vehicle was maintained during administration using a magnetic stirrer.

Test Item Administration:
One day before treatment, the backs of the animals were clipped with an electric clipper, exposing an area of approximately 10% of the total body surface. Only those animals without injury or irritation on the skin were used in the test. On test day 1, the test item was applied evenly on the intact skin with a syringe and covered with a surgical gauze pad (ca. 5 x 5 cm) held in contact with the skin by means of an adhesive hypoallergenic aerated semi-occlusive dressing and an elastic adhesive restrainer bandage wrapped around the abdomen.
The application volume was 6 mL/kg.
Twenty-four hours after the application the dressing was removed and the skin was flushed with lukewarm tap water and drapped off with disposable paper towels. Thereafter, the reaction sites were assessed. All animals were re-shaved on test day 8 to facilitate the reading of the local reactions.
Rationale: Dermal administration was used as this is one possible route of human exposure during manufacture, handling and use of the test item.

Duration of exposure:

24 hours

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

5 males and 5 females

Control animals:

not required

Details on study design:

Purpose:
The purpose of this study was to assess the acute dermal toxicity of Hostapon SG dried when administered to rats by single semi-occlusive dermal application, followed by an observation period of 14 days. This study should provide a rational basis for risk assessment.

Vehicle:
The vehicle was chosen after a non-GLP solubility trial which was performed before the study initiation date. Therefore, solubility testing was excluded from the statement of compliance. According to the Sponsor, the test item is soluble in water up to a concentration of 25%. Therefore, polyethylene glycol 300 (PEG 300) was used as vehicle and the test item could be dispersed at the technically highest concentration of 33 % (w/w). This was achieved with an Ultra Turrax and resulted in a white liquid, which was considered dermally applicable.
The following information was provided by Harlan Laboratories Ltd.:
Identification: Polyethylene glycol 300 (PEG 300)
Description: Colorless viscous liquid
Lot Number: STBB 3451
Source: Sigma-Aldrich Chemie GmbH, Riedstr. 2, D-89555 / Germany
Stability of the Vehicle: Stable under storage conditions
Expiry Date: 30-Apr-2012
Storage Conditions: At room temperature (range of 20 ± 5 °C), light protected.
Safety Precautions: Routine hygienic procedures were used to ensure the health and safety of the personnel.

Observations:
Viability / Mortality: Daily during the acclimatization period. Once before treatment, within the first 30 minutes and at approximately 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during days 2-15.
Clinical Signs: Daily during the acclimatization period. Once before treatment, within the first 30 minutes and at approximately 1, 2, 3 and 5 hours after administration on test day 1. Once daily during days 2-15. All abnormalities will be recorded.
Local Dermal Signs: Once daily during days 2 (following dressing removal) through day 15 using the numerical scoring system described in Appendix I.
Body Weights: On test days 1 (prior to administration), 8 and 15.

Pathology:
Necropsy: All animals were sacrificed at the end of the observation period by carbon dioxide asphyxiation and discarded after macroscopic examinations were performed. An external examination and opening of the abdominal and thoracic cavities for examinations of major organs was performed. The appearance of any macroscopic abnormalities was recorded. No organs or tissues were retained.

Data Compilation:
Viability/mortality was recorded on data sheets.
Body weights were recorded on-line with the ToxControl Computer System.
Clinical signs, local dermal signs, mortality data and macroscopic findings were compiled into the ToxControl Computer System during recording.
The ToxControl Computer System has been licenced for Harlan Laboratories Ltd. and validated with respect to data collection, storage and retrievability.

Statistics:

No statistical analysis was used.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No intercurrent deaths occurred during the course of the study.

Clinical signs:

other: No clinical signs were recorded throughout the entire observation period.

Gross pathology:

No macroscopic findings were recorded at necropsy.

Local dermal signs:

Very slight to slight erythema was observed on test day 2 (1 male) or from test day 2 to test day 4 (1 female) or test day 6 (1 male). Very slight to slight oedema and slightly maculated crusts were observed in one female (No. 10) from test day 2 to 3 or from test day 7 to 15, the end of the observation period. Slight desquamation was noted in one male and three females during test day 3 to test day 7 or 11 and in one male from test day 8 to test day 12. Slight to moderate desquamation was noted in one female from test day 3 to test day 14. The test item caused white to yellow discoloration of the treated skin in two males and one female on test day 2.

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 > 2000 mg/kg body weight

Executive summary:

The acute dermal toxicity of the registration substance Hostapon SLG was evaluated based on the read-across approach using the acute dermal toxicity data of Hostapon SG.

The acute dermal toxicity of Hostapon SG (70% sodium N-cocoyl glycinate) was investigated in an OECD 402 study in accordance with the principles of GLP. Five male and five female Wistar rats were treated with the test substance at 2000 mg/kg by dermal application. The test item was formulated in polyethylene glycol 300 as vehicle. The application period was 24 hours. Following a 14 day observation period all animals were necropsied and examined macroscopically. No intercurrent deaths occurred and no clinical signs were recorded throughout the entire observation period. The only substance related effects consisted of very slight to slight dermal irritation reactions in form of erythema and/or oedema in one male and two females during the observation period. No macroscopic findings were observed at necropsy. Based on the study results the median lethal dose (LD50) of Hostapon SG (70% sodium N-cocoyl glycinate) after single dermal administration to rats of both sexes was greater than 2000 mg/kg body weight.

Likewise, no concern can be derived for the registration substance Hostapon SLG.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

Due to the lower content of actives in Hostapon SG used in the acute oral toxicity study, the repeated dose toxicity study (28 -day) was further used as supporting evidence for low acute oral toxicity.

Justification for classification or non-classification

The registration Substance Hostapon SLG is of low acute toxicity based on the read-across to Hostapon SG.

Hostapon SG (25% Sodium N-Cocoyl Glycinate) caused no effect at single oral application of 2000 mg/kg/day in acute oral toxicity study and and no significant toxic effect in 28 -day repeated dose toxicity study at 1000 mg/kg/day. No classification is assigned to Hostapon SLG for acute oral toxicity.

Hostapon SG (70% Sodium N-Cocoyl Glycinate) did not cause any effect at single dermal application (24h patch application) of 2000 mg/kg/day. No classification is assigned to Hostapon SLS for acute dermal toxicity.