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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
28.11.1983 to 23.01.1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to a test protocol that is comparable to the appropriate OECD test guideline. It was not compliant with GLP.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Principles of method if other than guideline:
Method: other: variation of Magnusson and Kligman method
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The study was conducted in 1983. At this time the GPMT was the standard regulatory protocol and the LLNA had not been developed.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Aminotris(methylenephosphonic acid) (CA3). No indication of active acid concentration
No further details available in report.

In vivo test system

Test animals

Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS

- Source: Winkelmann, Borchen

- Weight at study initiation: average 430g for dosed animals, 423g for control animals

- Housing: Type 4 Makrolon cages

- Diet: Specialfeed Altromin 3022, ad libitum

- Water: tap water, ad libitum



ENVIRONMENTAL CONDITIONS

- Temperature (°C): ca. 23

- Humidity (%): 50-65

- Photoperiod (hrs dark / hrs light): 12/12


Study design: in vivo (non-LLNA)

Induction
Route:
intradermal
Vehicle:
water
Concentration / amount:
5%
Challenge
Route:
other: epicutaneous (need translation)
Vehicle:
water
Concentration / amount:
5%
No. of animals per dose:
20

Study design: in vivo (LLNA)

Vehicle:
other: aqueous solution
Concentration:
5%
No. of animals per dose:
20

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
5%
No. with + reactions:
0
Total no. in group:
19
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
test group
Dose level:
5%
No. with + reactions:
0
Total no. in group:
19

Any other information on results incl. tables

TEST SUBSTANCE GROUP RESPONSES

One animal died immediately after the intracutaneous application, with bleeding from the nose.

No evidence of sensitisation was observed.  Necropsy findings included catarrhal enteritis, bulging stomach and cecum (indigestion), pulmonary congestion, enlarged left side of the heart. Clear structure of the liver lobules.



CONTROL GROUP RESPONSES

One animal died during the exposure.

No evidence of sensitisation was observed.  After removal of patch one animal had white dots in left eye.

OTHER: The Freund’s adjuvant resulted in necrosis which resulted in scar tissue during the treatment free period of the experiment. After the Patch-test with of 48 hours general redness was seen and the injection sites were blood stained. Crust formation was present at injection sites in both the test and control animals.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
In a skin sensitisation study conducted using a protocol which was a variation of the Magnusson and Kligman method (reliability score 2), ATMP was not sensitising to the skin of guinea-pigs.
Executive summary:

In a skin sensitisation study conducted using a protocol which was a variation of the Magnusson and Kligman method (reliability score 2), ATMP (in water) was applied to the skin of 20 Pirbright guinea-pigs, 20 additional guinea-pigs served as negative controls. One animal from the test and control group died, and the study was negative for skin sensitisation (48 and 72 hours after exposure). Further details are available in the study report, but this needs proper translation.