Fatty acids, C9, hexaesters with dipentaerythritol

Endpoint summary

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

August 2002

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Read across study

Justification for type of information:

Based on its composition and physico chemical properties, fatty acids, C5-9, hexaesters with dipentaerythritol is considered to be a suitable read across substance to address the skin irritation endpoint of the test substance, fatty acids, C9, hexaesters with dipentaerythritol.

Reason / purpose for cross-reference:

read-across source

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

Deviations:

no

GLP compliance:

not specified

Test system:

human skin model

Remarks:

Reconstructed Human Epidermis (RHE)

Source species:

human

Cell type:

non-transformed keratinocytes

Vehicle:

unchanged (no vehicle)

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

test material used as received, undiluted

Duration of treatment / exposure:

1, 4, and 24 h

Number of replicates:

each treatment was conducted in duplicate

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

ET50 (hr) > 24

Value:

88.4

Vehicle controls validity:

not applicable

Negative controls validity:

not applicable

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Interpretation of results:

GHS criteria not met

Conclusions:

The substance produced an ET50 > 24 h, indicating that it was non-irritating under the study conditions.

Executive summary:

A study was conducted to evaluate the skin irritation potential of the read across substance, fatty acids, C5-9, hexaesters with dipentaerythritol, according to a method similar to OECD Guideline 439. MatTek EpiDerm tissue samples were exposed to undiluted substance for 1, 4 or 24 h. Following treatment, the viability of the tissues was determined using MTT uptake and conversion, and the absorbance of each sample was measured at 450 nm using a reference wavelength of 690 nm. The viability was then expressed as a percent of the control values. The mean percent viability for each time point was used to calculate an ET50 which represents the time at which the EpiDerm tissue viability was reduced by 50% compared to the control tissues. The substance produced an ET50 > 24 h, indicating that it was non-irritating under the study conditions (DeGeorge, 2002).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

August 7, 2002

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Based on its composition and physico chemical properties, fatty acids, C5-9, hexaesters with dipentaerythritol is considered to be a suitable read across substance to address the eye irritation endpoint of the test substance, fatty acids, C9, hexaesters with dipentaerythritol.

Reason / purpose for cross-reference:

read-across source

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)

Version / remarks:

MatTek EpiOcular MTT Viability Assay.
Draize correlation

Deviations:

no

GLP compliance:

not specified

Species:

other: MatTek EpiOcular tissues

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent negative control

Amount / concentration applied:

100 µl test material used as received undiluted

Duration of treatment / exposure:

4, 16, 64, and 256 min

Number of animals or in vitro replicates:

Each treatment was conducted in duplicate

Irritation parameter:

other: Viability assay %

Run / experiment:

256 min

Value:

66.9

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

not applicable

Remarks on result:

no indication of irritation

Interpretation of results:

GHS criteria not met

Conclusions:

The substance produced an ET50 > 256 min, indicating that it was non- to minimally irritating under the study conditions.

Executive summary:

A study was conducted to evaluate the skin irritation potential of the read across substance, fatty acids, C5-9, hexaesters with dipentaerythritol, according to a method similar to OECD Guideline 492. MatTek EpiOcular tissue samples were exposed to undiluted substance for 16, 64 or 256 min. Following treatment, the viability of the tissues was determined using MTT uptake and conversion, and the absorbance of each sample was measured at 540 nm using a reference wavelength of 690 nm. The viability was then expressed as a percent of the control values. The mean percent viability for each time point was used to calculate an ET50 which represents the time at which the EpiOcular tissue viability was reduced by 50% compared to the control tissues. The substance produced an ET50 > 256 min, indicating that it was non- to minimally irritating under the study conditions (DeGeorge, 2002).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation

A study was conducted to evaluate the skin irritation potential of the read across substance, fatty acids, C5-9, hexaesters with dipentaerythritol, according to a method similar to OECD Guideline 439. MatTek EpiDerm tissue samples were exposed to undiluted substance for 1, 4 or 24 h. Following treatment, the viability of the tissues was determined using MTT uptake and conversion, and the absorbance of each sample was measured at 450 nm using a reference wavelength of 690 nm. The viability was then expressed as a percent of the control values. The mean percent viability for each time point was used to calculate an ET50 which represents the time at which the EpiDerm tissue viability was reduced by 50% compared to the control tissues. The substance produced an ET50 > 24 h, indicating that it was non-irritating under the study conditions (DeGeorge, 2002).

Eye irritation

A study was conducted to evaluate the skin irritation potential of the read across substance, fatty acids, C5-9, hexaesters with dipentaerythritol, according to a method similar to OECD Guideline 492. MatTek EpiOcular tissue samples were exposed to undiluted substance for 16, 64 or 256 min. Following treatment, the viability of the tissues was determined using MTT uptake and conversion, and the absorbance of each sample was measured at 540 nm using a reference wavelength of 690 nm. The viability was then expressed as a percent of the control values. The mean percent viability for each time point was used to calculate an ET50 which represents the time at which the EpiOcular tissue viability was reduced by 50% compared to the control tissues. The substance produced an ET50 > 256 min, indicating that it was non- to minimally irritating under the study conditions (DeGeorge, 2002).

Justification for classification or non-classification

Based on the results of in vitro studies with the read across substance, fatty acids, C5-9, hexaesters with dipentaerythritol, the test substance does not require classification for skin or eye irritation according to EU CLP (EC 1272/2008) criteria.