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Diss Factsheets

Administrative data

Description of key information

There are no skin sensitisation data available for DTPMP-xNH4. 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
Reason / purpose for cross-reference:
read-across: supporting information
Qualifier:
no guideline followed
Principles of method if other than guideline:
This study was conducted before OECD TG 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
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
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
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
2.5%
No. with + reactions:
0
Total no. in group:
4
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
4
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
2.5%
No. with + reactions:
0
Total no. in group:
4
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
4
Remarks on result:
no indication of skin sensitisation
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
Reading:
2nd reading
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
4
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
4
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Group:
positive control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
0
Remarks on result:
other: There is no information about positive control.
Reading:
2nd reading
Group:
positive control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
0
Remarks on result:
other:
Remarks:
There is no information about positive control group.

All animals gained weight during the study.

Interpretation of results:
GHS criteria not met
Conclusions:
In a guinea pig maximisation study conducted before OECD TG 406 and GLP (reliability score 2), DTPMP was 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-xNH4, 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 the adoption of OECD Test Guideline 406 and pre-dating 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.

In a supporting skin sensitisation study (Buehler test), conducted prior to GLP and national guidelines (reliability score 2), DTPMP-H was not sensitising to the skin of guinea pigs (P&G, 1977).

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-xNH4 according to Regulation (EC) No 1272/2008.