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Administrative data

Description of key information

In a skin irritation study conducted to OECD 404 and GLP (Springborn Laboratories, 2000) DTPMP-xNa was very mildly irritating to the skin of rabbits.

In an eye irritation study conducted to OECD 405 and GLP (Springborn Laboratories, 2000b) DTPMP-xNa was not irritating to the eyes of rabbits.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
No data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Principles of method if other than guideline:
Method: other: Protocol number L-58081-R013. Insufficient detail presented to assess comparability with guideline.
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: No data
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: No data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data


IN-LIFE DATES: No data
Type of coverage:
not specified
Preparation of test site:
other: intact and abraded
Vehicle:
other: aqueous solution, administered undiluted.
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml. Although the recommended dose of 0.5 ml was achieved for the formulation, this means that the limit dose for the active salt was not attained. The level of irritation of the anhydrous active salt may therefore be underestimated by this study.
Duration of treatment / exposure:
no data
Observation period:
72 hours
Number of animals:
Six
Details on study design:
TEST SITE
- Area of exposure: No data
- % coverage: No data
- Type of wrap if used: No data


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

SCORING SYSTEM: No data (assumed to be Draize)
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 and 72 hour
Score:
0.4
Max. score:
8
Reversibility:
other: Essentially reversible in 72 hours
Remarks on result:
other: Based on combined intact and abraded skin.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within:
Remarks:
48 h
Remarks on result:
probability of weak irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 48 and 72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal: #2, #3, #4, #5, #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Intact skin: 24 hours after the end of exposure 1/6 rabbits had grade 1 erythema, which reversed by 72 hours. There was no oedema in any of the animals.
Abraded skin: 24 hours after the end of exposure 4/6 rabbits had grade 1 erythema, which remained in only one animal by 72 hours. There was no oedema in any of the animals.
Other effects:
None

Group total (intact skin) = 1, group total (abraded skin) = 5 
PDII = 6/24 = 0.25

Interpretation of results:
GHS criteria not met
Conclusions:
In a pre-GLP skin irritation study (reliability score 2) conducted prior to the adoption of OECD test guidelines, and available in summary only, Dequest 2060 was slightly irritating to rabbit skin.
Executive summary:

In a pre-GLP skin irritation study (reliability score 2) conducted prior to the adoption of OECD test guidelines, and available in summary only, 0.5 ml undiluted Dequest 2060 was applied to the intact and abraded skin of six New Zealand white rabbits (duration not given). After removal of dressings, skin reactions were graded (scoring system not given) at 24 and 72 hours. 24 hours after the end of exposure to intact skin, 1/6 rabbits had grade 1 erythema, which reversed by 72 hours. For abraded skin, 4/6 rabbits had grade 1 erythema 24 hours after the end of exposure, which remained in only one animal by 72 hours. There was no oedema in any of the animals. Dequest was therefore only slightly irritating to the skin of rabbits.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
27.07.1982 to 30.07.1982
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Remarks:
aqueous solution, administered undiluted.
Controls:
not required
Duration of treatment / exposure:
4 hour(s)
Observation period:
72 hours
Number of animals:
Three
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
8
Remarks on result:
other: No signs of irritation observed in any animal.
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Other effects:
None

No skin reactions were present in any of the six animals at 1hr, 24hr, 48hr and 72hr following removal of the patch.

Interpretation of results:
GHS criteria not met
Conclusions:
In a skin irritation study conducted according to OECD 404 and to GLP (reliability score 1), Briquest 543-33S (DTPMP sodium salt) was not irritating to the skin of rabbits.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (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:
24.08.1982 to 27.08.1982
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Remarks:
aqueous solution, administered undiluted.
Controls:
not required
Amount / concentration applied:
Amount applied: 0.1 ml
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
Three
Details on study design:
Comment: other: No indication that eye was rinsed.
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 48 and 72
Score:
0
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
The test substance produced no evidence of an ocular irritation in any rabbit. A dulling of the normal lustre of the cornea was observed in all three rabbits at the one hour reading, accompanied in one rabbit by iritis. A diffuse crimson-red colouration of the conjunctivae accompanied by slight or distinct swelling with partial eversion of the eyelids was observed in two rabbits at this reading. Mild conjunctival inflammation and swelling was observed in the remaining animal. The reactons had reversed in all three animals by the 24 hour reading.
Other effects:
None reported.

CORNEA
No scored effects, but dulling of the cornea was observed in
all 3 animals, 1 hour after dosing.  Total score 0.

IRIS
Score 1 in 1 animal, 1 hour after dosing.  Total score 1.

CONJUCTIVAL REDNESS
Score 2 in 2 animals and score 1 in the third, 1 hour after
dosing.  Total score 5.

CONJUNCTIVAL CHEMOSIS
Score 2 in 1 animal and score 1 in 2 animals, 1 hour after
dosing.  Total score 4.  

From 24 hours after dosing, no abnormal symptoms observed
any animal.  

Group total score = 10.

Interpretation of results:
GHS criteria not met
Conclusions:
In an eye irritation study conducted to OECD 405 and GLP (reliability score 1) Briquest 543-33S (sodium salt of DTPMP) was 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

The most reliable studies were selected as the key studies. The supporting studies also show the sodium salts of DTPMP are, at most, mildly irritating to the skin and eyes of rabbits.

Justification for classification or non-classification

The classification decisions for skin and eye irritation for the DTPMP salts are dependent on the ionisation state and conclusions are based on experimental evidence in the key skin and eyes studies in rabbits. Therefore, based on this information, no classification is required for DTPMP (5-7Na) according to Regulation (EC) No 1272/2008.