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Administrative data

Description of key information

Skin irritation studies indicate that solutions of LAS TEA (60%/50%) are at least irritating to the skin of rabbits. An eye irritation study with the test product suggest that it causes irreversible damage to the eye of rabbits. 

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:
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:
other: mean 24, 48 and 72 h
Score:
2.6
Max. score:
3
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: mean 24, 48 and 72 h
Score:
2
Max. score:
2
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean 24, 48 and 72 h
Score:
2.3
Max. score:
3
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: mean 24, 48 and 72 h
Score:
1.3
Max. score:
2
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean 24, 48 and 72 h
Score:
3
Max. score:
3
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: mean 24, 48 and 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)
Remarks:
Migrated information Criteria used for interpretation of results: EU
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 a dermal irritant. Given the results seen with a 60% mixture it is proposed to classify concentrations at greater than 60% as Corrosive category 1C.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (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: Study performed according to the guidelines. No GLP reference.
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:
other: mean 24, 48 and 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:
other: mean 24, 48 and 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:
other: mean 24, 48 and 72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 17 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean 24, 48 and 72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: mean 24, 48 and 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:
other: mean 24, 48 and 72 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: mean 24, 48 and 72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: mean 24, 48 and 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:
other: mean 24, 48 and 72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 10 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: mean 24, 48 and 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:
other: mean 24, 48 and 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:
other: mean 24, 48 and 72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 17 days
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
other: mean 24, 48 and 72 h
Score:
1.3
Max. score:
2
Reversibility:
fully reversible within: 10 days
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
other: mean 24, 48 and 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:
other: mean 24, 48 and 72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 17 days
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
other: mean 24, 48 and 72 h
Score:
1.3
Max. score:
2
Reversibility:
fully reversible within: 6 days
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
other: mean 24, 48 and 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:
other: mean 24, 48 and 72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
other: mean 24, 48 and 72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 8 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: mean 24, 48 and 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)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
On the basis of this result Marlopon AT50 can cause eye damage.
Executive summary:

In a primary eye irritation study 0.1 mL of  Marlopon AT50 (CAS 68411-31-4;50% linear alkenylbenzene sulfonate triethanolamine -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). The eyes were not washed after application of the test product. Animals then were observed for 21days.  Irritation was scored by the method of Draize. Unlike all the other endpoints, 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 classification criteria of CLP 1272/2008 and the results of this study Marlopon AT50 shall be classified as damaging to the eye.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

LAS TEA:

In a relaible 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 another 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.

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). The eyes were not washed after application of the test product. Animals then were observed for 21days.  Irritation was scored by the method of Draize.Unlike all the other endpoints, 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 classification criteria of CLP 1272/2008 and the results of this study Marlopon AT50, and hence, Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., compds. with triethanolamine shall be classified as damaging to the eye.

Supporting information 

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. The eyes were not irrigated. Eyes were examined and scored according to Draize et al. (1944) 1, 3, 7, 14, and 21 days after dosing. 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.


Justification for selection of skin irritation / corrosion endpoint:
The most reliable study available on the substance

Justification for selection of eye irritation endpoint:
The only available study

Effects on skin irritation/corrosion: irritating

Effects on eye irritation: highly irritating

Justification for classification or non-classification

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