Registration Dossier

Administrative data

Description of key information

Skin irritation

LAS TEA:

In a reliable in vivo skin irritation study, New Zealand white rabbits were dermally exposed to a solution of LAS-TEA (60% solution) for 4 hours and an occlusive dressing was applied. The test material was irritating to the skin. In a second unreliable skin irritation study, rabbits were dermally exposed to a solution of LAS-TEA (50% solution) for 4 hours and an occlusive dressing was applied. Within 24 hours after application of the test material a slight necrosis and hardening of the skin were observed. On the 6th and 8th days scabs were seen in almost all treated animals suggesting corrosive effects.

Supporting information on analogues

LAS Na:

Skin irritation data from a single study that is comparable to guideline studies is available. The study shows that LAS Na is irritant to the skin (Cat. 2) according to GLP based on persistent irritation.

TEA:

Data for TEA suggest that it is not irritating to the skin, eyes and respiratory tract. In a skin irritation test performed according to OECD 404, three rabbits were exposed to TEA using an occlusive application for 4 hours. The test substance was not a skin irritant. Several other studies, in which rabbits were exposed for up to 20 hours, yielded similar results (BASF 1956, 1966, 1967, 1971).

In a study with 6 human volunteers, 2 cm2-patches soaked with the test material were applied for 24 hours to the upper arm, and skin irritation was scored upon patch removal and 24 hours thereafter (BASF AG, 1930). Besides slight biting and reddening in 1 subject, no irritation was observed and thus, the test substance was judged non-irritating.

 

Eye irritation

LAS TEA:

In a primary eye irritation study 0.1 mL of  Marlopon AT50 (CAS 68411-31-4; 50% LAS TEA , 1% neutral oil, 1% triethanolamine, 3.5% treithanolamine sulfate, water) was instilled into the conjunctival sac of the right eye of white rabbits (3/sex). Corneal opacity effects were not fully reversible within 21 days post-application for almost all the animals tested. This suggests that the substance may have caused permanent damage. Based on the results of this study the substance is classified as damaging to the eye.

Supporting information on analogues (not provided)

LAS Na:

An eye irritation study comparable to OECD guideline 404 shows that LAS Na is a Category 1 eye irritant.

 

TEA:

In an eye irritation test equivalent to OECD guideline 405, 6 rabbits/dose were exposed to undiluted TEA at dose volumes of 0.01, 0.03, and 0.1 ml. TEA was not an eye irritant under the conditions of this study (, 1980). The same conclusion was reached in an eye irritation test (non GLP-compliant, according to internal BASF standards), in which 50 µl of the test substance was instilled into the eyes of 2 rabbits, and irritation was scored 10 min, 1 and 24 hours and 8 days after administration (BASF AG, 1971). In addition, no eye irritation was observed in response to the application of 0.5 mL 20% TEA in water at pH 10 and pH 8 (BASF AG, 1956). Two other studies (performed according to internal BASF standards) demonstrated some mild irritation due to the application of 50 µl undiluted TEA to the rabbit eye, which was not fully reversible within 8 days in one animal (BASF AG, 1966, 1967). Overall, TEA is judged not to be irritating to the eyes.


Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No GLP reference
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
:no data on the observation period
Qualifier:
according to
Guideline:
other: modified Department of Transportation Regulation (US), Method of testing corrosion to skin
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
not specified
Controls:
not required
Duration of treatment / exposure:
4 hours
Observation period:
no data
Number of animals:
3
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.6
Max. score:
3
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.3
Max. score:
3
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.3
Max. score:
2
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
no data
Other effects:
No escharosis or necrosis observed in any of the animals tested.
Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
On the basis of this result the test material (60% solution) is irritating to the skin of rabbits.
Executive summary:

In a primary dermal irritation study, New Zealand white rabbits were dermally exposed to 0.5ml of Bio-Soft N300 (60% LAS TEA) for 4 hours. Irritation was scored at 4, 24, 48 and 72 h post application. In this study, Bio-Soft N300 is irritating to skin.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
06.12.1983 - 20.12.1983
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Study performed according to OECD Guidelines, but with an important deviation that lead to an invalid result.
Remarks:
No rationale for in-vivo testing given; Occlusive conditions used (instead of the semi-occlusive as advised by the guideline 404), which may have contributed to a greater intensity of erythema/oedema;
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
: the coverage used was occlusive
GLP compliance:
not specified
Species:
rabbit
Strain:
other: Chbb
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Fa. Dr. Karl Thomae GmbH, Biberach
- Weight at study initiation: 1.9 to 2.2 kg
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ±1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL of test material (50% active ingredient)
VEHICLE
- Amount(s) applied (volume or weight with unit): no vehicle used
Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
3 males and 3 females
Details on study design:
TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: linen textile 2.5*2.5, covered up with a polyethylene coverage (6*6 cm)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes with distilled water
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize scale

Erythema and Eschar Formation
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar
formation (injuries in depth) 4

Oedema Formation
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well defined by definite raising) 2
Moderate oedema (raised approximately 1 millimetre) 3
Severe oedema (raised more than 1 millimetreand extending beyond area of exposure) 4

Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 3
Max. score:
3
Reversibility:
other: the scab was lost and scar tissue was formed
Remarks on result:
positive indication of irritation
Remarks:
Moderate to severe erythema
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 2
Max. score:
2
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Remarks:
Slight oedema
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 3
Max. score:
3
Reversibility:
other: the scab was lost and scar tissue was formed
Remarks on result:
positive indication of irritation
Remarks:
Moderate to severe erythema
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 2
Max. score:
2
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Remarks:
Slight oedema
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 3
Max. score:
3
Reversibility:
other: the scab was lost and scar tissue was formed
Remarks on result:
positive indication of irritation
Remarks:
Moderate to severe erythema
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 2
Max. score:
2
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Remarks:
Slight oedema
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
ca. 3
Max. score:
3
Reversibility:
other: the scab was lost and scar tissue was formed
Remarks on result:
positive indication of irritation
Remarks:
Moderate to severe erythema
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
ca. 2
Max. score:
2
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Remarks:
Slight oedema
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
ca. 2
Max. score:
2
Reversibility:
other: the scab was lost and scar tissue was formed
Remarks on result:
positive indication of irritation
Remarks:
Moderate to severe erythema
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
ca. 3
Max. score:
3
Reversibility:
other: the scab was lost and scar tissue was formed
Remarks on result:
positive indication of irritation
Remarks:
Moderate to severe erythema
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
ca. 2
Max. score:
2
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Remarks:
Slight oedema
Irritant / corrosive response data:
Within 24 hours after application of the test material a slight necrosis and hardening of the skin were observed. The response data for erythema and edema can be seen in the table above. On the 6th and 8th days scabs were seen in all treated animals (except for No5). Based on this information the test material shall be considered as highly irritating borderline to corrosive to the skin.
Interpretation of results:
Category 1C (corrosive) based on GHS criteria
Conclusions:
Under the conditions of this study, the test material Marlopon AT 50 (50% LAS TEA) has been shown to be corrosive to the skin of rabbits. However, the validity of this result is considered ambiguous.
Executive summary:

In a primary dermal irritation study,young adut male and female Chbb rabbits were dermally exposed to 0.5 mLof Marlopon AT 50 (50% Linear Alkylbenzene Sulfonate Triethanolamine (LAS TEA) , 1% neutral oil, 1% triethanolamine, 3.5% treithanolamine sulfate, water) in for 4 hours to 6 cm2of body surface area.  An occlusive dressing was applied. Animals were then observed for14 days.  Irritation was scored by the method of Draize. Within 24 hours after application of the test material a slight necrosis and hardening of the skin were observed. The response data for erythema and edema can be seen in the table above. On the 6th and 8th days scabs were seen in all treated animals (except for No5). Erythema and oedema were observed in all animals. Within 10 to 14 days after application the formed scab was lost and scar tissue was observed on the skin surface.In this study, Marlopon AT 50 is corrosive to the skin.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

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:
29th November 1983 - 20th December 1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
not specified
Species:
rabbit
Strain:
other: small white Russian, Chbb-SPF
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Fa. Dr. Karl Thomae GmbH, Biberach
- Weight at study initiation: 1.9 to 2.2 kg
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ±1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

VEHICLE no vehicle used, the product was applied as such
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure:

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: hand-slit lamp and fluorescein
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: scoring for all males
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: male
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 17 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: male
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.3
Max. score:
2
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: male
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 10 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 1.3
Max. score:
2
Reversibility:
fully reversible within: 6 days
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: female
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 17 days
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1.3
Max. score:
2
Reversibility:
fully reversible within: 10 days
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: female
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 17 days
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1.3
Max. score:
2
Reversibility:
fully reversible within: 6 days
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: female
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 8 days
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: scoring for all females
Irritant / corrosive response data:
The reaction scoring can be seen in the table above. The test material induce eye irritation to all animals.

Unlike the other endpoints, corneal opacity effects, although described as moderate irritation, were not fully reversible within 21 days post-application for almost all the animals tested. This suggests that the substance may have caused permanent damage to the eye of the rabbit.

Interpretation of results:
Category 1 (irreversible effects on the eye)
Conclusions:
On the basis of this result Marlopon AT50 can cause serious eye damage.
Executive summary:

In a primary eye irritation study 0.1 mL of  substance was instilled into the conjunctival sac of the right eye of white rabbits (3/sex). The eyes were not washed after application of the substance. Animals were observed for 21 days. Irritation was scored by the method of Draize. Unlike all the other effects measured (such as appearance of iris, conjunctivae, chemosis and discharge) corneal opacity effects were not fully reversible within 21 days post-application for almost all the animals tested. This suggests that the substance may have caused permanent damage to the eye of the rabbit.

Based on the results of this study the substance is classified as damaging to the eye (Category 1).

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Based on the results of the available studies on the substance and on two analogues, the substance is classified as Corrosive category 1C, H314 at concentrations greater than 50%. The substance is also classified as Eye Damage category 1, H318.