Registration Dossier

Administrative data

Description of key information

There are no skin sensitisation data available for DTPMP (5 -7Na). Therefore, data are read-across from the Category member, DTPMP-H.

In the key in vivo skin sensitisation study, conducted prior to OECD Test Guideline 406 and GLP, DTPMP-H (56.5% w/w total active acid) was concluded to be not sensitising to the skin of guinea-pigs (Unilever, 1979).

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
21.02.1979 to 27.06.1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
no guideline followed
Principles of method if other than guideline:
This study was conducted before OECD Test Guideline 406 was available. It was conducted according to the Magnusson and Kligman guinea pig maximisation test.
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
An LLNA study was not performed because there is an existing reliable study for skin sensitisation using the Guinea Pig Maximisation test method, which pre-dates REACH Regulation (EC No 1907/2006) and CLP Regulation (EC No 1272/2008).
Species:
guinea pig
Strain:
not specified
Sex:
not specified
Route:
intradermal and epicutaneous
Vehicle:
physiological saline
Concentration / amount:
Induction (intradermal injection): 1%
Induction (epicutaneous patch): 10%
Challenge 1: 2.5%
Challenge 2: 2.5%
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
physiological saline
Concentration / amount:
Induction (intradermal injection): 1%
Induction (epicutaneous patch): 10%
Challenge 1: 2.5%
Challenge 2: 2.5%
No. of animals per dose:
Ten per challenge phase
Details on study design:
PRELIMINARY IRRITATION TESTS
Intradermal injection: previously untreated guinea pigs of the same sex and weighing approximately 320g were each injected intradermally on the clipped flanks with 0.1 ml aliquots of a range of concentrations of test substance in a suitable solvent. 24 hours later the reactions were examined for size erythema and oedema. The concentration which produced a definite irritation reaction (10 x 10 mm, pale pink, with or without oedema) was selected as the intradermal injection induction concentration.
Topical application (for neck induction and flank challenge) : 8mm diameter filter paper (Whatman 3B01) patches, in 11 mm "Fintest" aluminium patch test cups, were saturated with a range of concentrations of test substance in a suitable solvent and the cups applied to the shaved flanks of previously untreated guinea pigs of the same sex and weighing approximately 450g. The patches were held in place by adhesive plaster (Poroplast) wound around the trunk. 24 hours later the patches are removed, the reaction sites were examined 24 and 48 hours subsequently. The concentration that gave definite irritation was selected for shoulder induction. The highest non-irritant concentration was selected for sensitisation challenge.

Induction:
- Intradermal injection:
1) 2 injections of 50% F.C.A. in the solvent system chosen for the test sample.
2) 2 injections of test material at the concentration and in the solvent system chosen in the preliminary irritation tests. These injections were given into the periphery of the "bleb" caused by injection 1.
3) 2 injections of the test material of the concentration chosen in the preliminary irritation tests in a 50/50 mixture of F.C.A. and the chosen solvent system.
- Epicutaneous induction: 7 days later sensitisation was boosted by placing over the shoulder injection site a 2 x 4cm filter paper patch saturated with test substance at the selected concentration. The patch was occluded with thin polythene, held in place by Poroplast, and was left in place for 48 hours.

Challenge: 14 days after application of the shoulder patch the guinea pigs were challenged on one flank by occluded patch. For each animal an 8mm diameter filter paper patch in a patch test cup is saturated with test solution at the selected concentration. The cup is applied to the shaved flank and is held in place by Poroplast wound around the trunk. 24 hours later the patch was removed, the reaction was examined 24 and 48 hours subsequently. One week later the challenge was repeated on the opposite flank.
Challenge controls:
- Treated controls (First challenge only): guinea pigs of the same sex and weighing about 320g were treated exactly as the test animals, except that test substance was omitted from the intradermal injection and covered patch induction procedures. The treatment was given to the control animals at the same time as to the test animals. The animals were challenged exactly as the test animals
- Untreated controls (All challenges) At each challenge 4 previously untreated animals of the same sex and weighing the same as the test animals were each challenged in the same way as the test animals.
Positive control substance(s):
not specified
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
2.5%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Remarks:
Challenge 1
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
2.5%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Remarks:
Challenge 1
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
2.5% (treated controls)
No. with + reactions:
0
Total no. in group:
4
Remarks on result:
no indication of skin sensitisation
Remarks:
Challenge 1
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
2.5% (treated controls)
No. with + reactions:
0
Total no. in group:
4
Remarks on result:
no indication of skin sensitisation
Remarks:
Challenge 1
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0% (untreated controls)
No. with + reactions:
0
Total no. in group:
4
Remarks on result:
no indication of skin sensitisation
Remarks:
Challenge 1
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
0% (untreated controls)
No. with + reactions:
0
Total no. in group:
4
Remarks on result:
no indication of skin sensitisation
Remarks:
Challenge 1
Key result
Reading:
2nd reading
Hours after challenge:
24
Group:
test chemical
Dose level:
2.5%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Remarks:
Challenge 2
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
2.5%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Remarks:
Challenge 2
Key result
Reading:
2nd reading
Hours after challenge:
24
Group:
negative control
Dose level:
0% (untreated controls)
No. with + reactions:
0
Total no. in group:
4
Remarks on result:
no indication of skin sensitisation
Remarks:
Challenge 2
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0% (untreated controls)
No. with + reactions:
0
Total no. in group:
4
Remarks on result:
no indication of skin sensitisation
Remarks:
Challenge 2
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
Not specified
No. with + reactions:
0
Total no. in group:
0
Remarks on result:
other: Data on positive control was not specified.
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
Not specified
No. with + reactions:
0
Total no. in group:
0
Remarks on result:
other: Data on positive control was not specified.

All animals gained weight during the study.

Interpretation of results:
GHS criteria not met
Conclusions:
In an in vivo skin sensitisation study, conducted prior to OECD Test Guideline 406 and GLP, DTPMP acid was concluded to be not sensitising to the skin of guinea-pigs.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

There are no skin sensitisation data available for DTPMP (5-7Na). Therefore, data are read-across from the Category member, DTPMP-H. See attachments to Section 13 for justification of read-across.

In the key in vivo skin sensitisation study, conducted prior to OECD Test Guideline 406 and GLP, DTPMP-H (56.5% w/w total active acid) was concluded to be not sensitising to the skin of guinea-pigs (Unilever, 1979).

On study day 0, 10 guinea pigs were induced by three intradermal injections (0.1 ml). The injections were: (1) 50% Freund's complete adjuvant plus in physiological silane, (2) a 1% (w/v) dilution of test material in physiological silane, (3) a 1% (w/v) dilution of test material in a 50/50 mixture of Freund's complete adjuvant plus physiological silane. On day 7, the animals were induced for second time by topical application of 10% v/v test material onto the skin of the same region previously used for intradermal injections. The test material was kept in contact with the skin under occluded dressing for 48 hours. 4 treated control animals were exposed exactly as the test animals, except that test substance was omitted from the intradermal injection and covered patch induction procedures.

Challenge was performed 14 days after the last induction application, on study day 21. During challenge, 2.5% v/v test material was applied topically for 24-hours under occlusive dressing onto the skin of the test animals. Following dressing removal, the skin reactions were assessed at 24 and 48 hours. The treated control animals were challenged in the same manner as the test animals. In addition, 4 untreated control group of animals was used, which were not induced, but were exposed to the test material during challenge only.

No skin reactions were reported in any of the test animals at either 24 or 48 hours after challenge. Negative controls were valid.


Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available data for DTPMP-H, no classification for skin sensitisation is required for DTPMP (5-7Na) according to Regulation (EC) No 1272/2008.