Registration Dossier
Registration Dossier
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EC number: 944-399-8 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Remarks:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: patch test based on OECD 404
- GLP compliance:
- yes
- Specific details on test material used for the study:
- OTHER SPECIFICS: Tradename Lorol 14/Lorol C12-98
- Species:
- other: human volunteers
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 22-53 years with an average of 34.9 years. - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 15 drops/plaster - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- 20
- Details on study design:
- TEST SITE
- Area of exposure: 1.5 cm diameter
- Type of wrap if used: plaster (diameter: 1.5 cm)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not specified
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 1, 24, 48 and 72 hours after application
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- other: No irritation was observed following application to the human skin of undiluted test substance for 4 hours.
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- other: No irritation was observed following application to the human skin of undiluted test substance for 4 hours.
- Irritation parameter:
- other: scaling and fissures
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- other: No irritation was observed following application to the human skin of undiluted test substance for 4 hours.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Lorol C14 is not irritating to human skin following a 4 hour semi-occlusive exposure in .
- Executive summary:
The IUCLID dataset of 1-Tetradecanol (CAS 112-72-1, Tradename Lorol 14) in the OECD SIDS Initial Assessment Profile Long Chain Alcohols describes the following Klimisch 1 patch test in healthy human volunteers.
Fifteen drops of undiluted test substance were added to a semi-occlusive plaster (diameter: 1.5 cm) and applied for 4 hours to the backs of healthy volunteers with age between 22-53 years. 20 Male and female volunteers were tested. The observation of edema, erythema, scaling and fissures was made at 1, 24, 48 and 72 hours after application.
No irritation was observed following application to the human skin of undiluted test substance for 4 hours (patch test). Lorol 14 is not irritating to human skin following a semi-occlusive exposure.
(Reference: Henkel KGaA, 1996 HD-Ocenol 90/95 V, Lorol C12-98, Lorol-C14-98, Lorol Spezial. 4h Patch Test (in Anlehnung an OECD Guideline Nr. 404). Henkel KGaA 1996, Report No. R9601427).
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Qualifier:
- according to guideline
- Guideline:
- other: Contact laboratory protocol
- Version / remarks:
- 1977
- GLP compliance:
- no
- Specific details on test material used for the study:
- OTHER SPECIFICS: Tradename Alfol 14
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- occlusive
- Preparation of test site:
- other: intact and abraded
- Vehicle:
- other: gum tragacanth 1%
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1mL (500 mg Alfol 14)
- Concentration (if solution): 50% in 1% gum tragacanth
- Duration of treatment / exposure:
- 24 h
- Observation period:
- 72 h
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure:1 inch square
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Washed off the treated skin
- Time after start of exposure: 72 h
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 24, 48 and 72 hours after application
SCORING SYSTEM:
- Method of calculation: Draize et al, 1944 - Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 4.3
- Max. score:
- 8
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.43
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h. Erythema score intact: 2.4 at 72 h.
- Remarks on result:
- other: Individual scores 5/6 greater than 2.3
- Irritation parameter:
- erythema score
- Remarks:
- abraded skin
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.53
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h. Erythema score abraded: 2.8 at 72 h.
- Remarks on result:
- other: Individual scores 5/6 greater than 2.3
- Irritation parameter:
- edema score
- Remarks:
- intact skin
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.83
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h; Edema score abraded 1.5 at 72 h.
- Irritation parameter:
- edema score
- Remarks:
- abraded skin
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3.26
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h. Edema score intact: 1.3 at 72 h.
- Irritant / corrosive response data:
- Erythema increased or persisted until 72 hours after application while oedema decreased or persisted.
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- Based on the erythema and oedema scores reported Alfol 14 would be considered a skin irritant according to EU criteria and a class 2 irritant according to GHS criteria. Individual 24+48+72 hour erythema scores were >2.3 in 5/6 animals while the group mean 24+48+72 hour score was also in excess of 2.3 (2.46).
- Executive summary:
The IUCLID dataset of 1-Tetradecanol (CAS 112-72-1, Tradename Alfol 14) in the OECD SIDS Initial Assessment Profile Long Chain Alcohols describes the following Klimisch 2 study according to contract laboratory protocol in 6 New Zealand White rabbits (1977).
500 mg Alfol 14 was applied at a volume of 1 mL as a 50% suspension in 1% of gum tragacanth to 1 inch square of intact and abraded skin for a 24 hours occlusive exposure. After 24 hours the test substance was washed off the treated skin.
Observations were made 24, 48 and 72 hours post application. Scoring system of Draize was used.
The average score after 24+48+72 hours were
- Erythema: Intact skin 2.43, abraded skin 2.53 (72 hours score intact 2.4, abraded 2.8).
- Oedema: intact skin 1.83, abraded skin 3.26 (72 hours score intact 1.3, abraded 1.5.).
Alfol 14 was considered skin irritant according to EU criteria and a class 2 irritant according to GHS criteria.
(Reference: Scientific Associates, Inc. 1977b. Acute oral toxicity (LD50) in rats, acute dermal toxicity (LD50) in rabbits, dermal irritation test in rabbits, eye irritation test in rabbits, and inhalation toxicity test in rats. ALFOL 14 alcohol.)
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Specific details on test material used for the study:
- OTHER SPECIFICS: Tradename Kalcol 6098
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival, Cheshire, UK
- Age at study initiation: 12 -16 weeks
- Weight at study initiation: 2.36 - 2.54 kg - Type of coverage:
- semiocclusive
- Preparation of test site:
- not specified
- Vehicle:
- other: The test material was a white solid, the test site was moistened with 0.5 mL purified water prior to application of 0.5 g of the solid.
- Controls:
- other: not reported
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of the solid
VEHICLE
- Amount(s) applied (volume or weight with unit): the test site was moistened with 0.5 mL purified water prior to application of 0.5 g of the solid. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- Postexposure period: 16 days
- Number of animals:
- 3 (2 male, 1 female)
- Details on study design:
- TEST SITE
- % coverage: 2.5 x 2.5 cm
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Gentle swabbing with cotton.
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 1, 24, 48 and 72 hours post application.
SCORING SYSTEM:
- Method of calculation: Draize - Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 24 hours
- Remarks:
- Initial erythema regressed in the first 24 hours. All scores at 24, 48 and 72 hours were 0.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: Erythema (grade 1) observed at 1 hour after removal of dressings. All scores at other time points 0.
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: No oedema observed.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Following a 4 hour semi-occlusive exposure of Kalcol 6098 to rabbit skin there was no evidence of skin irritation between 24 and 72 hours after patch removal. All erythema and oedema scores at 24, 48 and 72 hours were 0 and primary dermal irritation index was 0 . Kalcol 6098 is not a skin irritant according to EU or GHS criteria.
- Executive summary:
The IUCLID dataset of 1-Hexadecanol (CAS 36653-82-4, Tradename Kalcol 6098) in the OECD SIDS Initial Assessment Profile Long Chain Alcohols describes one Klimisch 1 study according to OECD TG 404 in 3 New Zealand White rabbits.
The test material was a white solid, the test site was moistened with 0.5 mL purified water prior to semi-occlusive application of 0.5 g of the solid on an area of 2.5 x 2.5 cm. After 4 hours exposure the test substance was removed by gentle swabbing with cotton.
Observations were made 1, 24, 48 and 72 hours post application. Scoring system of Draize was used. Post-exposure period was 16 days.
Erythema (grade 1) was observed at 1 hour after removal of dressings. All scores at other time points were 0. No oedema observed. Initial erythema regressed in the first 24 hours. All scores at 24, 48 and 72 hours were 0. Primary dermal irritation index was 0.
Following a 4 hour semi-occlusive exposure of Kalcol 6098 to rabbit skin there was no evidence of skin irritation between 24 and 72 hours after patch removal. Kalcol 6098 is not a skin irritant according to EU or GHS criteria.
(Reference: Sanders, A. 1996b.Kalcol 6098: Acute dermal irritation test in the rabbit. SPL Project Number 140/496.)
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Remarks:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Specific details on test material used for the study:
- OTHER SPECIFICS: Tradename Kalcol 8098
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd, Cheshire, UK
- Age at study initiation:12-16 weeks
- Weight at study initiation: 2.56 - 2.73 kg - Type of coverage:
- semiocclusive
- Preparation of test site:
- not specified
- Vehicle:
- other: The test material was a white solid, the test site was moistened with 0.5 ml distlled water prior to application.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of the solid.
VEHICLE
- Amount(s) applied (volume or weight with unit): the test site was moistened with 0.5 mL distilled water prior to application of 0.5 g of the solid.
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: .2,5 x 2.5 cm
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 24, 48 and 72 hours post application
SCORING SYSTEM:
- Method of calculation: Draize - Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- other: not applicable, not irritating
- Remarks on result:
- other: No evidence of skin irritation was noted during the study, all scores were 0.
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Following a 4 hour semi-occlusive exposure to rabbits skin Kalcol 8098 was non-irritating to rabbit skin. All erythema and oedema scores at 24, 48 and 72 hours in rabbits were 0 and primary dermal irritation index was 0. Kalcol 8098 is not a skin irritant according to EU or GHS criteria.
- Executive summary:
The IUCLID dataset of 1-Octadenol (CAS 112-92-5) in the OECD SIDS Initial Assessment Profile Long Chain Alcohols describes the following Klimisch 1 study according to OECD Guideline 404 "Acute Dermal Irritation/Corrosion" in 3 New Zealand White rabbits.
The test material was a white solid, the test site was moistened with 0.5 mL distilled water prior to semi-occlusive application of 0.5 g of the solid on an area of 2.5 x 2.5 cm. The exposure period was 4 hours, the post-exposure preiod was 72 hours. Observations were made 24, 48 and 72 hours post application. Scoring system of Draize was used.
Primary dermal irritation index was 0. No evidence of skin irritation was noted during the study, all scores were 0.
Following a 4 hour semi-occlusive exposure to rabbits skin, Kalcol 8098 was non-irritating. Kalcol 8098 is not a skin irritant according to EU or GHS criteria.
(Reference: Sanders, A. 1996c. Kalcol 8098: Acute dermal irritation test in the rabbit. SPL Project Number 140/502.)
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1984
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Remarks:
- Guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Specific details on test material used for the study:
- OTHER SPECIFICS:
C12 > 98 %
25 % active substance - Species:
- rabbit
- Strain:
- other: Kleinrusse Chbb:HM
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Thomae, Germany
- Age at study initiation:
- Weight at study initiation: 2048 - 2308 g
- male animals - Type of coverage:
- occlusive
- Vehicle:
- other: not specified
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 25 % active substance was used
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 21 days
- Number of animals:
- 5
- Details on study design:
- TEST SITE
- Area of exposure: : 2.5 cm2
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not further specified
OBSERVATION TIME POINTS
1, 24, 48 and 72 hrs and on days 7, 10, 14, 17 and 21
SCORING SYSTEM:
- Method of calculation: Draize - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 3.4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 10 d
- Score:
- 3.6
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 14 d
- Score:
- 1.2
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 17 days
- Score:
- 0.6
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 21 d
- Score:
- 0.4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 1.4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 3.4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 3.8
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 3.8
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 10 d
- Score:
- 2.4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 14 d
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 17 days
- Score:
- 0.4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 21 d
- Score:
- 0.2
- Max. score:
- 4
- Reversibility:
- not reversible
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- Based on the description of the lesions and the non-reversibility of the effects over the 21 days observation period it is considered that C12-Alkylsulfate is skin irritating.
- Executive summary:
The IUCLID dataset of C12-Alkylsulfate (CAS 151-21-3) in the OECD SIDS Initial Assessment Profile on Sodium dodecyl sulfate (SDS) describes the following Klimisch 1 study according to OECD Guideline 404
Skin irritation was tested in male Kleinrusse Chbb:HM rabbits.
0.5 mL of test material (25% of the active substance) was applied in an area of 2.5 cm2. Observations were made until 21 days post application. Scoring system of Draize was used. Based on the description of the lesions and the non-reversibility of the effects over the 21 days observation period it is considered that C12-Alkylsulfate(SDS) is skin irritating.
Reference: Henkel KGaA (1987) Aniontenside, Kationtenside, Amphotenside, Niotenside - Pruefung auf primaere Hautirritation (Unpublished Report No. TBD 870150). Henkel KGaA, Duesseldorf, 21 pp.
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Remarks:
- Guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Remarks:
- no deviations reported
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: HC:NZW
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Interfauna, Ltd, UK
- Age at study initiation: adults
- Weight at study initiation: 3.7 - 4.2 kg
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- other: polyethyleneglycol 400
- Remarks:
- PEG 400
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg (500 mg pulverized in PEG 400)
NEGATIVE CONTROL
Contralateral skin area not treated
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: dorso-lateral areas of the trunk.
- Type of wrap if used: Patches hypoallergenic Hansamed (Beiersdorf)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed with water
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
-1, 24, 48, 72 hours, 7, 14 days.
SCORING SYSTEM:
- Method of calculation: DRAIZE - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 14 d
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 14 d
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Not irritating.
- Executive summary:
The IUCLID dataset of Na2SO4 (CAS 7757 -82 -6) in the OECD SIDS INITIAL ASSESSMENT PROFILE of Sodium sulfate describes the following Klimisch 1 study according to OECD Guideline 404.
Skin irritation was tested under occlusive conditions in 3 HC:NZW rabbits. 500 mg of test material was pulverized in PEG 400 and applied on the dorso-lateral area of the trunk and covered for 4 hours with hypoallergenic Hasamed patches. Observations were made until 14 days post application. Scoring system of Draize was used. Sodium sulfate is considered not skin irritating.
Reference: Bayer, A.G.(1991) Study for skin and eye irritation/corrosion in rabbits. Unpublished report. Study no. T7039997, Report no. 20338, Wuppertal, Germany.
Data source
Materials and methods
Test material
- Reference substance name:
- Sulfuric acid, C16-C18 (even numbered) alkyl esters, sodium salts and C16-18 (even numbered) alcohols
- EC Number:
- 944-399-8
- Cas Number:
- not yet assigned
- Molecular formula:
- see information in structural formula
- IUPAC Name:
- Sulfuric acid, C16-C18 (even numbered) alkyl esters, sodium salts and C16-18 (even numbered) alcohols
Constituent 1
Results and discussion
In vivo
Results
- Remarks on result:
- other: see remarks
- Remarks:
- C14 LCHO and C12-Alkylsulfate, covering 2.4% of the registered substance, are classified Skin irritant CLP Category 2. LCOH16 and 18 and sodium sulfate, covering 88% of the registered substance, are not classified skin irritating or corrosive. Based on the generic concentration limits (CLP, 2008), the sum of the irritating ingredients is <10%, therefore the registered substance is not classified for skin irritation or corrosion.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- C14 LCHO and C12-Alkylsulfate, covering 2.4% of the registered substance, are classified Skin irritant CLP Category 2. LCOH16 and 18 and sodium sulfate, covering 88% of the registered substance, are not classified skin irritating or corrosive. Based on the generic concentration limits (CLP, 2008), the sum of the irritating ingredients is <10%, therefore the registered substance is not classified for skin irritation or corrosion.
- Executive summary:
C14 LCHO and C12-Alkylsulfate, covering 2.4% of the registered substance, are classified Skin irritant CLP Category 2. LCOH16 and 18 and sodium sulfate, covering 88% of the registered substance, are not classified skin irritating or corrosive. Based on the generic concentration limits (CLP, 2008), the sum of the irritating ingredients is <10%, therefore the registered substance is not classified for skin irritation or corrosion.
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