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Diss Factsheets

Administrative data

Description of key information

In the key in vivo skin irritation study, conducted according to OECD Test Guideline 404 and in compliance with GLP, ATMP-xNH4 was applied to the skin of New Zealand White rabbits under semiocclusive coverage. No dermal reactions were observed in any of the animals and it was concluded that the test substance is not a skin irritant under the conditions of the test (SafePharm Laboratories Ltd., 1995; reliability 1).

In the key in vivo eye irritation study, conducted according to OECD Test Guideline 405 and in compliance with GLP, 0.1 mL of undiluted ATMP-xNH4 was applied to the eye of New Zealand White rabbit. One of three rabbits had minimal irritation to one eye and it was concluded that the test substance is not irritating to eyes (SafePharm Laboratories Ltd., 1995; reliability 1).

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:
31.03.1995 to 03.04.1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK.
- Age at study initiation: 12 to 16 weeks
- Weight at study initiation: 2.3 to 2.61 kg
- Housing: Individually housed in suspended metal cages.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Minimum five days.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-21
- Humidity (%): 56-61
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 31.03.1995 To: 03.04.1995
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
Duration of treatment / exposure:
Four hours
Observation period:
72 hours
Number of animals:
Three
Details on study design:
TEST SITE
- Area of exposure: The back
- % coverage: No stated, but patch was 2.5 x 2.5
- Type of wrap if used: The trunk was wrapped in an elasticated corset.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, with cotton wool soaked in distilled water
- Time after start of exposure: Four hours


SCORING SYSTEM: Draize
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: all
Score:
0
Reversibility:
other: No irritation observed
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No dermal reactions observed.
Interpretation of results:
GHS criteria not met
Conclusions:
In a GLP, skin irritation study (reliability score 1) conducted to OECD 404, undiluted ammonium salt of ATMP (no information on composition of liquid tested) was not irritating to the skin of rabbits.
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:
10.04.1995 to 14.04.1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd, Sandbach Cheshire, UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.52 to 2.96 kg
- Housing: Individually in suspended metal cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: minimum five days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-21
- Humidity (%): 52-60
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 10.04.1995 To: 14.04.1995
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
No washing
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
Three
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No washing


SCORING SYSTEM: Draize


TOOL USED TO ASSESS SCORE: standard ophthalmoscope
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: no data
Score:
1.3
Reversibility:
fully reversible
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
Max. score:
4
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:
0.33
Max. score:
3
Remarks on result:
probability of weak irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Minimal conjunctival irritation (grade 1) was noted in one eye at the one and 24 hour observations.
Other effects:
None
Interpretation of results:
GHS criteria not met
Conclusions:
In an eye irritation study, conducted according to OECD Test Guideline 405 and in compliance with GLP, undiluted ammonium salt of ATMP was minimally irritating to one eye in one of three rabbits, so is concluded not to be irritating to eyes.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

In the key in vivo skin irritation study, conducted according to OECD Test Guideline 404 and in compliance with GLP, 0.5 mL of undiluted ATMP-xNH4 was applied to the skin of three New Zealand White rabbits under semiocclusive coverage for four hours. Thereafter, the area was washed with cotton wool soaked in distilled water and observation occurred for 72 hours. No dermal reactions were observed in any of the animals and it was concluded that the test substance is not a skin irritant under the conditions of the test (SafePharm Laboratories Ltd., 1995; reliability 1).

In the key in vivo eye irritation study, conducted according to OECD Test Guideline 405 and in compliance with GLP, 0.1 mL of undiluted ATMP-xNH4 was applied to the eye of three New Zealand White rabbit without any washing. One of three rabbits had minimal conjunctival irritation (grade 1) at the 1 and 24-hour observation. This observation does not upfill the criteria to be classified as an eye irritant so it was concluded that the test substance is not irritating to eyes under the conditions of the test (SafePharm Laboratories Ltd., 1995; reliability 1).

Justification for classification or non-classification

Based on the available data and knowledge of pH of the ammonium salts, ATMP-xNH4 does not require classification for skin or eye irritation/corrosion according to Regulation (EC) No. 1272/2008.