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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2015-06-17 until 2015-06-19
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: per guideline study (GLP)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report date:
2015

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Deviations:
yes
Remarks:
the deviation from SOP didn't impact the result of the study.
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
3,9-dimethyl-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane 3,9-dioxide
EC Number:
221-088-9
EC Name:
3,9-dimethyl-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane 3,9-dioxide
Cas Number:
3001-98-7
Molecular formula:
C7H14O6P2
IUPAC Name:
3,9-dimethyl-2,4,8,10-tetraoxa-3λ⁵,9λ⁵-diphosphaspiro[5.5]undecane-3,9-dione
Test material form:
solid: particulate/powder
Details on test material:
AFLAMMIT® PCO 962

In vitro test system

Test system:
human skin model
Source species:
other: SkinEthic Reconstituted Human Epidermis (RHE)
Cell type:
non-transformed keratinocytes
Details on test system:
Upon delivery, SkinEthic™ tissues (RHE/S/17) were treated according to the SOP.
At day 18, tissues were transferred to growth culture medium .Tissues were placed in
maintenance culture medium prior to application of test substances.

Test system

Details on study design:
The irritant potential of AFLAMMIT® PCO 962 was tested using the SkinEthic™ RHE model and expressed as a percent of the negative control tissue NC (exposed to Phosphate Buffer Saline, PBS).

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
% tissue viability
Value:
> 50
Vehicle controls validity:
not examined
Negative controls validity:
valid
Positive controls validity:
valid

Any other information on results incl. tables

 Treatment  Assay acceptance criterion  OD 570nm1  SD2
 PBS (NC)  0.8 <= OD <= 3  1.689  0.122
 SDS (PC)  -  0.020  0.001
 AFLAMMIT® PCO 962  -  1.790  0.041

 Treatment  Assay acceptance criterion  Viability %l  SD %2  I/NI3
 PBS (NC) SD <= 18%  100.0  7.22 NI
 SDS (PC)

 SD <= 18% and Viability < 40%

 1.2

 0.03

 I

 AFLAMMIT® PCO 962

  SD <= 18%

 106.0

 2.42

 NI

1: mean of 3 replicates

2: SD: Standard Deviation

3: I: Irritant; NI: Non Irritant

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The viability of the RHE in the presence of the test substance was above 50% at 42 minutes exposure and 42 hours recovery, following analysis by the MTT viability assay.
Therefore, the sample was classified as non-irritant.