Registration Dossier

Administrative data

Description of key information

Skin irritation: not irritating (US FHSA Federal regulation: 16 CFR 1500.41, pre-GLP), applied to intact and abraded skin for 24 h under occlusive dressing; no skin reactions
Eye irritation: not irritating (US FHSA Federal regulation: 16 CFR 1500.42, pre-GLP), no eye irritation observed

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:
1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test procedure according to national (US) standard. Observation period only 72 hours. No GLP.
Qualifier:
according to
Guideline:
other: Appraisal of the safety of chemicals in foods, druge and cosmetics, by the Staft of the Division of Pharmacology, US FDA, skin toxicity according to Draize (1959)
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
other: US FHSA Federal regulation: 16 CFR 1500.41
Deviations:
no
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 2.4 to 2.6 kg
- Housing: individually
- Diet (e.g. ad libitum): standard diet, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1°C
- Humidity (%): 45 to 55%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light):12/12

IN-LIFE DATES: no data
Type of coverage:
occlusive
Preparation of test site:
other: one test site shaved/intact + one test side ahaved/abraded
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated sites (one intact, one abraded) on each animal served as negative control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): used as suppplied
Duration of treatment / exposure:
24 h
Observation period:
72 h
Number of animals:
6
Details on study design:
TEST SITE
- The test material was applied to two clipped areas on each of six animals, one abraded and one left intact.
- Area of exposure: 2.5 x 2.5 cm
- Coverage ad wrap: Test sites were covered with medical strips which were fixed by leucoplast stripes. Whole animal trunk was wrapped in rubberized impervious cloth to minimize evaporation of the test substance. The animals were immobilized for the 24 hour exposure period.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data

SCORING SYSTEM: erythema/eschar and edema scoring similar to OECD guideline 404
Irritation parameter:
erythema score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
other: mean 24, 72 h
Score:
0
Max. score:
4
Remarks on result:
other: intact and abraded skin, no scoring at 48 h
Irritation parameter:
edema score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
other: mean 24, 72 h
Score:
0
Max. score:
4
Remarks on result:
other: intact and abraded skin, no scoring at 48 h
Irritant / corrosive response data:
Intact skin:
All animals showed no reactions at all.

Abraded skin:
All animals showed no reactions at all.
Other effects:
No other effects were observed.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)
Conclusions:
In this study, MAPTAC is not irritant to rabbit skin.
Executive summary:

In a primary dermal irritation study similar to US FHSA Federal regulation: 16 CFR 1500.41, 6 rabbits were dermally exposed to 0.5 mL of MAPTAC ( according to supplier: purity ca. 50 ± 1%) to approximately 2.5 cm² skin area. Two application sites per animal were treated, one site was left intact, the other was abraded. Test sites were covered with an occlusive dressing for 24 hours. Animals were observed for 72 hours. Irritation was scored according to FHSA Federal guideline 16 CFR 1500.41. This scoring system is similar to OECD guideline 404.

No dermal irritation response was observed, neither at the intact nor at the abraded application sites.

In this study, MAPTAC is not a dermal irritant.

Study performance does not comply with requirements of the relevant recent EU and OECD guidelines, where a less vigorous application regime with semi-occlusive dressing, an exposure period of 4 hours, treatment of only intact skin is stipulated.

Thus, it can be assumed, that a substance which shows no irritating activity under the application regime of guideline US FHSA Federal regulation: 16 CFR 1500.41 will also be non irritating under the application regimes of the relevant recent EU and OECD guidelines. Therefore the study is adequate for C&L purposes.

NOTE: Any of data in this dataset are disseminated by the European Union on a right-to-know basis and this is not a publication in the same sense as a book or an article in a journal. The right of ownership in any part of this information is reserved by the data owner(s). The use of this information for any other, e.g. commercial purpose is strictly reserved to the data owners and those persons or legal entities having paid the respective access fee for the intended purpose.

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:
1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test procedure according to national (US) standards comparable to international guidelines. Study performed before implementation of GLP.
Qualifier:
according to
Guideline:
other: US FHSA Federal regulation: 16 CFR 1500.42
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no
Remarks:
study performed before implementation of GLP
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 2.4 to 2.6 kg
- Housing: individually
- Diet (e.g. ad libitum): standard diet, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1°C
- Humidity (%): 45 to 55%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light):12/12

IN-LIFE DATES: no data
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated right eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
- Concentration (if solution): as supplied
Duration of treatment / exposure:
eyes were not rinsed after application
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): eyes were not rinsed for substance removal after treatment

SCORING SYSTEM: Draize scale

TOOL USED TO ASSESS SCORE: no data
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
other: mean 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
other: mean 24, 48, 72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
other: mean 24, 48, 72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
other: mean 24, 48, 72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
In all six treated animals, the cornea, iris as well as the conjunctiva were free of effects at all scorings.
Other effects:
no other effects observed
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)
Conclusions:
In this study, MAPTAC is not an eye irritant.
Executive summary:

In a primary eye irritation study according to US FHSA Federal regulation: 16 CFR 1500.42 (similar to OECD guideline 405), 0.1 g of MAPTAC ( according to supplier: purity ca. 50 ± 1%) was instilled into the conjunctival sac of the left eye 6 New Zealand White rabbits without removing the test substance. Animals then were observed for 7 days.  Irritation was scored by the method of Draize. No irritating effects were observed.

In this study, MAPTAC is not irritant to the rabbit eye.

NOTE: Any of data in this dataset are disseminated by the European Union on a right-to-know basis and this is not a publication in the same sense as a book or an article in a journal. The right of ownership in any part of this information is reserved by the data owner(s). The use of this information for any other, e.g. commercial purpose is strictly reserved to the data owners and those persons or legal entities having paid the respective access fee for the intended purpose.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Reliable (RL= 2), relevant and adequate data are available for the skin and eye irritation potential of MAPTAC.

Skin irritation

In a primary dermal irritation study similar to US FHSA Federal regulation: 16 CFR 1500.41, 6 rabbits were dermally exposed to 0.5 mL of MAPTAC ( according to supplier: purity ca. 50 ± 1%) to approximately 2.5 cm² skin area. Two application sites per animal were treated, one site was left intact, the other was abraded. Test sites were covered with an occlusive dressing for 24 hours. Animals were observed for 72 hours. Irritation was scored according to FHSA Federal guideline 16 CFR 1500.41. This scoring system is similar to OECD guideline 404.

No dermal irritation response was observed, neither at the intact nor at the abraded application sites.

In this study, MAPTAC is not a dermal irritant.

Study performance does not comply with requirements of the relevant recent EU and OECD guidelines, where a less vigorous application regime with semi-occlusive dressing, an exposure period of 4 hours, treatment of only intact skin is stipulated.

Thus, it can be assumed, that a substance which shows no irritating activity under the application regime of guideline US FHSA Federal regulation: 16 CFR 1500.41 will also be non irritating under the application regimes of the relevant recent EU and OECD guidelines. Therefore the study is adequate for C&L purposes.

 

 

Eye irritation

In a primary eye irritation study according to US FHSA Federal regulation: 16 CFR 1500.42 (similar to OECD guideline 405), 0.1 g of MAPTAC (according to supplier: purity ca. 50 ± 1%) was instilled into the conjunctival sac of the left eye 6 New Zealand White rabbits without removing the test substance. Animals then were observed for 7 days.  Irritation was scored by the method of Draize. No irritating effects were observed. In this study, MAPTAC is not irritating to the rabbit eye.

 

This finding is supported by a study performed before implementation of GLP:

In a primary eye irritation study according to US FHSA Federal regulation: 16 CFR 1500.42 (similar to OECD guideline 405), 0.1 g of MAPTAC (40% by weight in water) was instilled into the conjunctival sac of 6 Albino rabbits without removing the test substance. Animals then were observed for 72 hours.  No irritating effects were observed. In this study, MAPTAC is not irritating to the rabbit eye.

Respiratory irritation

No data on the respiratory irritation of MAPTAC are available.

 

There are no data gaps for the endpoint irritation/corrosion. No human information is available for this endpoint. However, there is no reason to believe that these results would not be applicable to humans.

 

Justification for selection of skin irritation / corrosion endpoint:
study similar to US FHSA Federal regulation: 16 CFR 1500.41, pre-GLP

Justification for selection of eye irritation endpoint:
study according to US FHSA Federal regulation: 16 CFR 1500.42, pre-GLP

Justification for classification or non-classification

Based on the available data, MAPTAC does not need to be classified for eye irritation or skin irritation according to regulation (EC) 1272/2008 or the former European directive on classification and labelling 67/548/EEC. Thus, no labelling is required.