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Diss Factsheets

Administrative data

Description of key information

In the key in vivo skin irritation study with DTPMP (1-3Na), conducted according to OECD Test Guideline 404 and in compliance with GLP, DTPMP (1-3Na) was not irritating to rabbit skin (Springborn Laboratories, 2000a, reliability score 1).


 


In the key in vivo eye irritation study with DTPMP (1-3Na), conducted according to OECD Test Guideline 405 and in compliance with GLP, DTPMP (1-3Na) was concluded to be not irritating to the eyes of rabbits (Springborn Laboratories, 2000b, reliability score 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:
10.05.2000 to 20.05.2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Myrtle's Rabbitry, Thompson Station, TN.
- Age at study initiation: 'adult'
- Weight at study initiation: 2.3 - 2.44 kg
- Housing: Individually in suspended stainless steel cages
- Diet (e.g. ad libitum): PMI certified rabbit chow #5322 (Purina Mills, Inc), ad libitum
- Water (e.g. ad libitum): Purified municipal tap water, ad libitum
- Acclimation period: Minimum of five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-22
- Humidity (%): 46-82
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: 10.05.2000 to 20.05.2000
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
-Applied under a 1 x 1 inch square patch of gauze held in place with non-irritating tape.
Duration of treatment / exposure:
Four hours
Observation period:
10 days
Number of animals:
1M 5F
Details on study design:
TEST SITE
- Area of exposure: Dorsal area of trunk
- % coverage: No data
- Type of wrap if used: The gauze patch was held in place around the cut edges with non-irritating tape, and ingestion prevented by placing an elastic wrap over the trunk and test area.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes
- Time after start of exposure: Residual test substance was removed using gauze moistened with deionised water followed by dry gauze.

SCORING SYSTEM: Based on Draize

Any unusual observations and/or mortality were recorded. General health checks were performed twice daily. Individual body weights were obtained prior to dosing.
Animals were examined for signs of erythema and oedema and the responses were scored at 1, 24, 48, and 72 hours post patch removal, and at 10 days post patch removal.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 10 days
Remarks on result:
probability of weak irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible
Remarks:
within 48 hours
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible
Remarks:
within 48 hours
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible
Remarks:
within 48 hours
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #6
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:
0.33
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Very slight to well-defined erythema on 6/6 test sites and very slight oedema on 3/6 test sites at the one hour scoring interval. The dermal irritation had resolved completely in all animals by day 10.
Other effects:
None reported.
Interpretation of results:
GHS criteria not met
Conclusions:
In the in vivo skin irritation study with DTPMP (1-3Na), conducted according to OECD Test Guideline 404 and in compliance with GLP, DTPMP (1-3Na) was not irritating to rabbit skin. The primary irritation scores was calculated to be 0.75, based on the EEC dermal evaluation criteria the test substance is considered to be a non-irritant to the skin of the rabbit based on erythema and oedema. The calculated primary irritation indices for erythema and oedema were 0.61 and 0.06 respectively.
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:
12.05.2000 to 15.05.2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Myrtle's Rabbitry, Thompson Station, TN.
- Age at study initiation: 'adult'
- Weight at study initiation: 2.5 - 2.9 kg
- Housing: Individually in suspended stainless steel cages.
- Diet (e.g. ad libitum): PMI certified rabbit chow #5322 (Purina Mills), ad libitum
- Water (e.g. ad libitum): Municipal tap water, ad libitum
- Acclimation period: Minimum of five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22
- Humidity (%): 46-82
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: 12.05.2000 to 15.05.2000
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:
24 hours - following this the eye was gently rinsed with physiological saline
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
6F
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes - at 24 hours

SCORING SYSTEM: EEC Ocular Evaluation Criteria

TOOL USED TO ASSESS SCORE: auxiliary light source, fluorescein

The eyes were macroscopically examined with the aid of an auxiliary light source for signs of irritation at 1, 24, 48 and 72 hours after dosing. Following macroscopic observations at the 24-hour scoring interval, the fluorescein examination procedure was repeated on all test and control eyes and any residual test article was gently rinsed from the eye at this time (if possible) using physiological saline. If any fluorescein findings were noted at 24 hours, a fluorescein exam was conducted on the affected eyes at each subsequent interval until a negative response was obtained. Any unusual observations and/or mortality were recorded. General health/mortality checks were performed twice daily. Individual body weights were obtained for each animal prior to dosing on day 0.
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 48 and 72 hour
Score:
4.11
Reversibility:
fully reversible
Remarks on result:
other: considered non-irritating
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 48 h
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 48 h
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:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #6
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
Max. score:
3
Reversibility:
fully reversible within: 72 h
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.66
Max. score:
3
Reversibility:
fully reversible within: 72 h
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.66
Max. score:
3
Reversibility:
fully reversible within: 72 h
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0.66
Max. score:
3
Reversibility:
fully reversible within: 72 h
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0.66
Max. score:
3
Reversibility:
fully reversible within: 72 h
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 h
Remarks on result:
no indication of irritation
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:
cornea opacity score
Basis:
animal #4
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 #5
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 #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
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
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Exposure to the test substance produced corneal opacity in 4/6 test eyes at the 1-hour scoring interval. The corneal opacity resolved in all test eyes by the 24-hour scoring interval. Iritis was observed in 6/6 test eyes at the 1-hour scoring interval and resolved completely in all test eyes by the 48-hour scoring interval. Conjunctivitis (redness, swelling and/or discharge) was noted in 6/6 test eyes at the 1-hour scoring interval. The conjunctival irritation resolved completely in all test eyes by the 72-hour scoring interval. Additional ocular findings included slight dulling of the normal luster of the cornea which was noted in 2/6 test eyes.
A mechanical abrasion was observed in 1/6 control eyes during the fluorescein examination, but was not considered to be significant due to its transient nature. No corneal opacity, iritis or conjunctivitis was observed in the control eyes.
Other effects:
None reported.
Interpretation of results:
GHS criteria not met
Conclusions:
In the in vivo eye irritation study with DTPMP (1-3Na), conducted according to OECD Test Guideline 405 and in compliance with GLP, DTPMP (1-3Na) was concluded to be not irritating to the eyes of rabbits.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation


In the key in vivo skin irritation study with DTPMP (1-3Na), conducted according to OECD Test Guideline 404 and in compliance with GLP, DTPMP (1-3Na) was not irritating to rabbit skin (Springborn Laboratories, 2000a reliability score 1). In the study, 0.5 ml of undiluted DTPMP (1-3Na) (aqueous solution containing 46.9% w/w active acid) was applied onto the skin of 6 rabbits for 4 hours under semi-occlusive dressing. At the end of the exposure period residual test substance was removed using gauze moistened with deionised water followed by dry gauze. Any unusual observations and/or mortality were recorded. General health checks were performed twice daily. Individual body weights were obtained prior to dosing. Very slight to well-defined erythema on 6/6 test sites and very slight oedema on 3/6 test sites were observed at the 1-hour scoring interval. The mean erythema score for animal #1 was 1 at 24/48/72 hours, while the mean erythema scores for animals #2, #3 and #4 were 0.33. The mean oedema skin reaction scores for animals #1, #2 and #3 were also 0.33 at 24/48/72 hours. The dermal irritation had resolved completely in all animals by day 10.


 


Eye irritation


In the key in vivo eye irritation study with DTPMP (1-3Na), conducted according to OECD Test Guideline 405 and in compliance with GLP, DTPMP (1-3Na) was concluded to be not irritating to the eyes of rabbits (Springborn Laboratories, 2000b, reliability score 1). In the study, 0.1 ml of undiluted DTPMP (1-3Na) (aqueous solution containing 46.9% w/w active acid) was instilled into the eyes of 6 rabbits. The eyes were macroscopically examined with the aid of an auxiliary light source for signs of irritation at 1, 24, 48 and 72 hours after dosing. Any unusual observations and/or mortality were recorded. General health/mortality checks were performed twice daily. Individual body weights were obtained for each animal prior to dosing on day 0. Exposure to the test substance produced corneal opacity in 4/6 test eyes at the 1-hour scoring interval. The corneal opacity resolved in all test eyes by the 24-hour scoring interval. Iritis was observed in 6/6 test eyes at the 1-hour scoring interval and resolved completely in all test eyes by the 48-hour scoring interval. Conjunctivitis (redness, swelling and/or discharge) was noted in 6/6 test eyes at the 1-hour scoring interval. The conjunctival irritation resolved completely in all test eyes by the 72-hour scoring interval. Additional ocular findings included slight dulling of the normal lustre of the cornea which was noted in 2/6 test eyes. A mechanical abrasion was observed in 1/6 control eyes during the fluorescein examination, but was not considered to be significant due to its transient nature. No corneal opacity, iritis or conjunctivitis was observed in the control eyes.

Justification for classification or non-classification

Based on the available data, DTPMP (1-3Na) does not require classification for skin or eye irritation according to Regulation (EC) No 1272/2008.