Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Piperazine (CAS No 110-85-0) is the parent molecule from which piperazine, compound with phosphoric acid or piperazine phosphate (CAS No 1951-97-9) is synthesized. In medicine piperazine is used in the form of the hexahydrate or as the citrate, tartrate, phosphate (1951-97-9) or adipate. Thus, piperazine and piperazine phosphate can be considered as belonging to the same category. There are reliable reports indicating that phosphoric acid possesses properties indicating a hazard for human health (acute toxicity to respiratory tract, corrosivity to skin and eye, and moderate repeated dose toxicity. However, based on the exposure data; the exposure to humans with phosphoric acid is expected to be minimal. Also, it is important to note that Piperazine by virtue of its highly basic nature shall exhibit more corrosive properties than phosphoric acid. Based on the above, it is has been considered that the properties of piperazine (parent molecule) shall have an important influence on the toxicological properties of piperazine phosphate. Thus, Piperazine (CAS No 110-85-0) has been used as a read across substance, especially for the toxicological end points in this dossier preparation.

Data source

Reference
Reference Type:
other: study report
Title:
European Union Risk Assessment Report : Piperazine
Author:
European Chemicals Bureau
Year:
2005
Bibliographic source:
3rd Priority List Volume: 56;Final Report, 2005

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
Piperazine
EC Number:
203-808-3
EC Name:
Piperazine
Cas Number:
110-85-0
IUPAC Name:
piperazine

Test animals

Species:
rabbit
Strain:
other: Weisser Wiener
Details on test animals or test system and environmental conditions:
Two males and one female were kept individually and the fur was removed by close clipping at least 15 hours pre dosing.About 0.5 g of piperazine in a 50% aqueous solution (assumingly piperazine base) was applied to a 6.25 cm2 gauze patch and applied to the skin and covered with a semi-occlusive dressing.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
not specified
Controls:
not specified
Duration of treatment / exposure:
4 hrs
Observation period:
30-60 minutes, 24, 48 and 72 hours
Number of animals:
Two males and one female

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48
Reversibility:
no data
Remarks on result:
other: Severe erythema was observed in all animals after 48hrs.
Irritation parameter:
other: necrosis
Basis:
mean
Time point:
other: 48
Reversibility:
no data
Remarks on result:
other: Severe necrosis was observed in all animals after 48hrs.
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72
Reversibility:
no data
Remarks on result:
other: Severe erythema was observed in all animals after 72 hours.
Irritation parameter:
other: necrosis
Basis:
mean
Time point:
other: 72
Reversibility:
no data
Remarks on result:
other: Severe necrosis was observed in all animals after 72 hours.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In an acute dermal irritation/corrosion test conducted according to OECD Guideline 404, piperazine was found to be strongly irritating to the skin of white rabbits, strain “Weisser Wiener”.
After exposure for 4 hours, the test substance was removed, and the skin reaction evaluated after 30-60 minutes, 24, 48 and 72 hours, respectively. Severe erythema and necrosis was observed in all animals after 48 and 72 hours.
Executive summary:

In an acute dermal irritation/corrosion test conducted according to OECD Guideline 404, piperazine was found to be strongly irritating to the skin of white rabbits, strain “Weisser Wiener”.

After exposure for 4 hours, the test substance was removed, and the skin reaction evaluated after 30-60 minutes, 24, 48 and 72 hours, respectively. Severe erythema and necrosis was observed in all animals after 48 and 72 hours.