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Administrative data

Description of key information

CHPTAC (65%) was tested negative for skin and eye irritation properties in tests conducted according to OECD 404 and OECD 405.

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Reference:
Composition 0
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
Cited as Directive 84/449/EEC, B.4
GLP compliance:
not specified
Remarks:
RAR, 2008 and IUCLID indicate GLP compliance, the study report does not.
Test material information:
Composition 1
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Froxfield Rabbits, Petersfield, Hants, UK
- Age at study initiation: 11-12 wk
- Weight at study initiation: 2.4-2.7 kg
- Housing: 1/metal cage with perforated floor
- Diet: standard diet ad libitum
- Water: drinking water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): approx 19
- Humidity (%): 3-=70
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12 h/12 h


IN-LIFE DATES: From: To:
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 mL CHPTAC 65 % (as supplied)
Duration of treatment / exposure:
4 h
Observation period:
4 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm2
- Type of wrap if used: semi-occlusive

REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 30 mins, days 2, 3, 4
Score:
0
Reversibility:
other: not applicable
Remarks on result:
other: 4-h exposure
Irritant / corrosive response data:
Not irritating
Interpretation of results:
GHS criteria not met
Remarks:
Migrated information
Conclusions:
A guideline study found the test material (65% aqueous CHPTAC) to be non-irritant when in semi-occluded contact with rabbit skin for 4 h.
Executive summary:

 In a study conducted according to EU guideline, three New Zealand White rabbits received a 0.5ml dose of 65% CHPTAC in water to a shaved region in the dorso-lumbar area. The test substance was applied to an area of 2.5cm2. The patch was semi-occluded with an adhesive dressing for 4 hours. After the removal of the semi-occlusive dressing the application area was washed. The skin was examined 30 minutes after the removal of the patches and on days 2,3 and 4. The scores were zero at all time points. The substance is not irritating to rabbit skin.

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
not specified
Test material information:
Composition 1
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Buckmasters, Henham, Herts, UK
- Age at study initiation: 20-24 wk
- Weight at study initiation: 2.2-3.1 kg
- Housing: 1/metal cage with perforated base
- Diet: standard diet ad libitum
- Water: drinking water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): approx 19
- Humidity (%): 30-70
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12 h/12 h
Vehicle:
unchanged (no vehicle)
Controls:
other: other eye serves as control
Amount / concentration applied:
Concentration: 65%
Amount applied: 0.1 mL
Duration of treatment / exposure:
examination after 1 h
Observation period (in vivo):
Examined at 1 h and 1, 2, 3, 4 and 7 days after instillation
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): none

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: hand torch
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.7
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.7
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.3
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
All symptoms were fully reversible within 96 hours.

Cornea: 0, 24, 72 h, 48 h: 1 animal: 1, 2 animals: 0,  Iris:
0 (3 animals, 24, 48, 72 h), 
Conjunctiva redness: 24 h: 2 (2 animals), 1 (1 animal)
                     48 h: 2 (3 animals)
                     72 h: 1 (3 animals)
After 4 and 7 days: 0 (3 animals).
Conjunctiva chemosis: 24 h: 2 (1 animal), 1 (2 animals)
                      48 h: 1 (3 animals)
                      72 h: 1 (2 animals), 0 (1 animal)
After 4 and 7 days: 0 (3 animals).

Interpretation of results:
GHS criteria not met
Remarks:
Migrated information
Conclusions:
A reliable study, conducted according to OECD 405 and GLP, reported transient irritation, particularly of the conjunctiva, from a 65% aqueous solution of CHPTAC, that had resolved by 96 h. The scores would not meet EU criteria for classification.
Executive summary:

In a primary eye irritation study (OECD 405), 0.1 mL of CHPTAC (65%) was instilled into the conjunctival sac of one eye of each of three young adult New Zealand White rabbits. Animals were observed for 7 days. Irritation was scored by the method of Draize. Only very mild conjunctival reactions were observed, which were fully reversible within 96 hours. In this study, the test item is not an eye irritant.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The key skin irritation study (Shell, 1987) was chosen from six studies, generating a similar classification, as the most recent study. The key study was of reliability 2 and the supporting studies comprised one of reliability 2, three of reliability 3 (reliable with restrictions; an absence of GLP) and one of reliability 4 (not assignable; very limited reports).

The key eye irritation/corrosion study was identified from seven giving broadly similar findings as the most recent study. The key study was of reliability 2. Supporting studies (reliability 2,3 and 4), indicated that the test material (55% or 60% CHPTAC or unspecified) was either slightly irritant or non-irritant. One study (QUAS048, reliability 2) produced results that were judged at the time to indicate a non-irritant material . The balance of findings from other studies (many of good quality) are that the test material (up to 65% CHPTAC, where specified) would not be classified as an eye irritant.

In the case of skin and eye irritation, it is not possible from the data identified to determine what the effect of the pure (100%) material might be.

Justification for classification or non-classification

Based on the available data, no classification for CHPTAC (65%) is warranted for skin and eye irritation.

In the case of skin and eye irritation, it is not possible from the data identified to determine what the effect of the pure (100%) material might be.