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Administrative data

Description of key information

The component PTSA is considered corrosive to the skin, while AMP is considered irritant. The invalid studies with a formulation of the substance show that it is irritant to the skin, but not corrosive.

For the eye, the actual substance was tested in vivo. An earlier study with a solution of the registered substance was tested and found to be corrosive. Due to the low quality of this study, a neat sample of the substance was tested under GLP conditions. In this study, the substance was found to be irritating to the eye. The higher quality study result was used for classification.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation / corrosion, other
Remarks:
in vivo study
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
Not applicable
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: meets generally accepted scientific standards, and acceptable for assessment
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study
Qualifier:
no guideline followed
Principles of method if other than guideline:
5 daily applications of test material to the shaved abdomen of rabbits.
GLP compliance:
no
Species:
rabbit
Strain:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS- Source: supplier of animals not indicated, however all animals were sourced from a single supplier- Age at study initiation: All animals indicated to be 'young and healthy' nof urther information is given- Weight at study initiation: no data is given- Housing: Animals housed individually in cages - Diet (e.g. ad libitum): standard diet provided ad libitum throughout the study- Water (e.g. ad libitum): ad libitum water- Acclimation period: no details givem
Type of coverage:
open
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
The paper indicates a 'measured' amount of test material was applied to the skin, however no further details are given
Duration of treatment / exposure:
The exposures were conducted daily for 5 days. The duration of the exposure was dependant upon the time until the test site appeared 'dry'. The test materials were not washed off after treatment
Observation period:
There is no data on the observation period. At a minimum it appears that the animals were observed for the full 5 days during treatment.
Number of animals:
number of animals used is not indicated in the report
Details on study design:
Animals were prepared by closely clipping the skin over the anterior abdominal wall. After securing the animal in the supine position, a measured amount of the test material was pipetted onto the surface of the skin. The test material was allowed to evaporate in still air, and the animal was released to the cage after the skin was dry. The treatments were repeated daily until 5 had been made.
Irritation parameter:
overall irritation score
Remarks:
No score available from study
Time point:
other: 5 days
Reversibility:
not specified
Remarks on result:
other: imited data available from literature source but sufficient to determine irritiability. Confirmed by additional testing
Irritant / corrosive response data:
No illness resulted from skin applications of the test material, and observations were limited to irritation. Two animals showed chemical dermititis, infiltration of the skin and subcutaneous tissues, superficial redness, and a considerable loss of hair. Burrowing lesions in the subcutaneous tissues were produced by the introduction of the test material into small wounds. There were no systemic effects noted and no significant bodyweight loss.

Highly irritating

Interpretation of results:
irritating
Remarks:
Migrated informationCriteria used for interpretation of results: expert judgment
Conclusions:
Even though the reporting of this work is limited, it is clear from the report that AMP is irritant under the described experimental conditions.
Executive summary:

An undisclosed number of rabbits were shaved free of hair on the anterior abdominal wall. The rabbits were then secured in the supine position on an animal board and a measured amount of test material was pipetted onto the shaved area. No details of dose or approximate area of application are given. After test material administration the animals were left secured to the board in still air conditions until the test site was dry. No occlusive dressing was used and the test material was allowed to evaporate. Once the test site was dry each animal was returned to it's cage. This procedure was repeated daily for 5 days after which the animals were assessed for signs of illness and local effects at the test site. No illness resulted from the application of test compound to the skin and there were no signs of systemic toxicity or weight loss during the study. AMP caused a low grade chemical dermititis in two animals, infiltration of the skin and subcutaneous tissues, superficial redness, and a considerable loss of hair. Burrowing lesions in the subcutaneous tissues were produced by the introduction of the test material into small wounds. Based on the results of this experiment, AMP is considered to be irritating to the skin.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline, GLP study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
physiological saline
Controls:
yes, concurrent no treatment
Duration of treatment / exposure:
4 hour
Observation period:
7 days
Number of animals:
1
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24-72 hr
Score:
3.7 - 4
Reversibility:
not fully reversible within: 7 days
Other effects:
Mean Edema score was 2.0
Brown discolouration

3 additional animals were exposed for 3 minutes each. The mean erythema score was 0.6 and the mean edema score was 0. Effect was reversible within 72 hours.

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance is corrosive to the skin. Washing immediately after exposure significantly reduced the severity and duration of the effect.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
Version / remarks:
Eye irritation, FHSLA, CFR, Title 21, para. 191.12
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
no details
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.1 mL
Observation period (in vivo):
at 24, 48 and 72 hours, and 4, 7 and 14 days after exposure
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): none:

SCORING SYSTEM: Draize ( Kay J.H.; Calandra J.C., Interpretation of Eye Irrftation Test J. Soc. Cos. Chem. 13:281:1962)

TOOL USED TO ASSESS SCORE: No data
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0.39
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
24/48/72 h
Score:
1.67
Max. score:
3
Reversibility:
fully reversible within: 14 days for 5/6 animals
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
1.39
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
discharge
Basis:
mean
Time point:
24/48/72 h
Score:
1.33
Max. score:
3
Reversibility:
fully reversible
Irritant / corrosive response data:
see individual animal data in the table below

Animal no 1 1 3
24 48 72 4 7 14 24 48 72 4 7 14 24 48 72 4 7 14
cornea  1 1 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0
iris 0 0 0 0 0 0   0 0 0 0 0 0 0 0 0 0 0
conjunctivae                                    
redness 2 1 0 0 1 0 1 2 1 0 0 0 1 2 1 0 0 0
chemosis 3 2 0 0 0 0 3 1 0 0 0 0 3 0 0 0 0 0
discharge 2 2 0 0 0 0 3 2 1 0 0 0 2 1 0 0 0 0
                                     
Animal no 4 5 6
24 48 72 4 7 14 24 48 72 4 7 14 24 48 72 4 7 14
cornea  0 0 0 0 0 0 3 3 3 3 1 0 0 0 0 0 0 0
iris 1 0 0 0 0 0 2 2 2 1 0 0   0 0 0 0 0
conjunctivae                                    
redness 2 0 0 0 0 0 2 3 1 2 1 1 2 0 0 1 1 0
chemosis 3 0 0 0 0 0 4 3 2 0 0 0 1 0 0 0 0 0
discharge 3 1 0 0 0 0 2 3 0 0 0 0 1 0 1 0 0 0
Interpretation of results:
GHS criteria not met
Conclusions:
the substance (formulation tested) is not irritant to the eyes
Executive summary:

The substance was applied to the eyes of 6 rabbits. Although initially irritant effects were observed, the results do not allow a conclusion that the tested formulation is an eye irritant.

Endpoint:
eye irritation, other
Remarks:
Conducted study is in vivo and was conducted prior to the requirement for in vitro studies and before these asays were perfected for use
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
Not applicable
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study appears to have been conducted in accordance to a standard protocol (at the time) for assessing the eye irritation potential of compounds. Although there is limited information on the methods used the reporting is sufficient to come to a conclusion on the endpoint.
Principles of method if other than guideline:
Draize technique (Draize, J.H., Woodard, G. & Calvery, H.O. (1944) Methods for the study of irritation and toxicity of substances applied topically to the skin and mucous membranes. J. Pharmacol. and Exp. Therapeutics. 82, 377–390.)
GLP compliance:
no
Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
No details given
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 ml undiluted
Duration of treatment / exposure:
Animals were dosed with the test material, in one study the eyes were flushed 15-30 seconds after application, and in the other, they were not. No further methods information was given.
Observation period (in vivo):
scoring of results took place at 24 and 48 hours after exposure only. No further information on any subsequent observation period.
Number of animals or in vitro replicates:
6 animals in each study
Details on study design:
No additional Information
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 48h
Score:
110
Max. score:
110
Reversibility:
not specified
Remarks on result:
other: un flushed eyes
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 48h
Score:
69.3
Max. score:
110
Reversibility:
not specified
Remarks on result:
other: eye flushed after 15 seconds
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 48h
Score:
89.3
Max. score:
110
Reversibility:
not specified
Remarks on result:
other: eye flushed after 30 seconds
Irritant / corrosive response data:
Unflushed eyes scored a 110 on the grading scale used, the highest possible. The test material had destroyed the vision. Flushed eyes scored 69.3/89.3 when flushed at 15 and 30 seconds, respectively. A score of 16 or higher is considered a severe irritant.
Other effects:
No details

Unflushed eyes scored a 110 on the grading scale used, the highest possible. The test material had destroyed the vision. Flushed eyes scored 69.3/89.3 when flushed at 15 and 30 seconds, respectively. A score of 16 or higher is considered a severe irritant.

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated informationCriteria used for interpretation of results: EU
Conclusions:
The test material is considered to be a severe eye irritant, and there is little beneficial effect even when eyes are almost immediately flushed with water.
Executive summary:

In two studies of the eye irritation potential of AMP in rabbits, AMP was applied to the eyes of 6 rabbits (Strain and sex not recorded). In one study, the eyes were flushed with water 15 to 30 seconds post application, in the second study the eyes were not flushed with water. AMP caused severe damage to the eyes and flushing almost immediately with water appeard to have little beneficial effect. The Damage caused by AMP appears likely to be due to the high pH rather than any other type of chemical damage.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

As the effects seen in the study with PTSA may be caused by the acidic nature of this substance, it is concluded that the salt in a weight of evidence approach is considered irritant to the skin.

For eye irritation in a worst case approach it is concluded that the substance is a severe eye irritant based on the data on AMP and the effects seen in the study with the formulation.

Justification for classification or non-classification

Based on the considerations above the substance is to be classified into Category 2 for skin irritation (H315) and Category 1 for serious damage to the eyes (H318) according to CLP (Regulation EC No 1272/2008)