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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study and GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Qualifier:
according to guideline
Guideline:
EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
GLP compliance:
yes (incl. QA statement)
Type of study:
mouse local lymph node assay (LLNA)

Test material

Constituent 1
Reference substance name:
Esterification product of castor oil and tetrahydromethyl-1,3-isobenzofuranedione
EC Number:
700-064-6
Cas Number:
2105830-60-0
Molecular formula:
Not applicable as this is a UVCB substance
IUPAC Name:
Esterification product of castor oil and tetrahydromethyl-1,3-isobenzofuranedione
Constituent 2
Reference substance name:
[TN]Multiester P97-463[/TN][SPEC][/SPEC][AM]100 %[/AM]
IUPAC Name:
[TN]Multiester P97-463[/TN][SPEC][/SPEC][AM]100 %[/AM]
Details on test material:
Multiester P97-463
Batch No. NB2890-61

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female

Study design: in vivo (LLNA)

Vehicle:
dimethylformamide
Concentration:
0, 25, 50, 100 %
No. of animals per dose:
5
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

Positive control results:
An EC3 value of 13.8 % was calculated using linear interpolation.

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: The SI values calculated for the substance concentrations 25, 50 and 100% were 7.2, 11.8 and 13.3 respectively.
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: Mean DPM/animal values for the experimental groups treated with test substance concentrations 25, 50 and 100% were 4029, 6576 and 7413 respectively. The mean DPM/animal value for the vehicle control group was 557.

Any other information on results incl. tables

Skin reactions / Irritation: No irritation of the ears was seen in the control group and the 25% test substance treated group. The slight irritation of the ears as shown by the animals of the 50 and 100% treated groups was considered not to have a toxicologically significant effect on the activity of the nodes. Macroscopy of the auricular lymph nodes and surrounding area: All nodes of the experimental animals treated at 25% and control group were considered normal in size. Enlarged nodes were found in the groups treated at 50 and 100%. No macroscopic abnormalities of the surrounding area were noted. Body weights: The slight body weight loss, noted in some experimental animals, was considered not toxicologically significant. Toxicity and mortality: No mortality occurred and no symptoms of systemic toxicity were observed in the animals of the main study.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information
Conclusions:
The SI values calculated for the substance concentrations 25, 50 and 100% were 7.2, 11.8 and 13.3 respectively.
These results indicate that the test substance could elicit a SI >= 3. No reliable EC3 value could be calculated. It would have been possible to strengthen the outcome of the study by adding lower concentrations. Since the SI values clearly exceeded 3 and since extension of the study would not alter the classification, this was considered not appropriate for ethical reasons.
The six monthly reliability check with Hexylcinnamaldehyde, indicates that the Local Lymph Node Assay as performed at NOTOX is an appropriate model for testing for contact hypersensitivity.
Based on these results:
- according to the recommendations made in the test guidelines, Multiester P97-463 would be regarded as skin sensitizer.
- according to the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) of the United Nations (2007), Multiester P97-463 should be classified as skin sensitizer (Category 1).
- according to the EC criteria for classification and labeling requirements for dangerous substances and preparations (Council Directive 67/548/EEC), Multiester P97-463 should be labeled as: may cause sensitization by skin contact (R 43).
Executive summary:

Test substance concentrations selected for the main study were based on the results of a preliminary study.

In the main study, three groups of five experimental animals were treated with test substance concentrations of 25%, 50% or 100% on three consecutive days, by open application on the ears. Five vehicle control animals were similarly treated, but with vehicle alone (Dimethyl formamide).

Three days after the last exposure, all animals were injected with 3H-methyl thymidine and after five hours the draining (auricular) lymph nodes were excised.

After precipitating the DNA of the lymph node cells, radioactivity measurements were performed. The activity was expressed as the number of Disintegrations Per Minute (DPM) and a stimulation index (SI) was subsequently calculated for each group.

No irritation of the ears was seen in the control group and the 25% test substance treated group. The slight irritation of the ears as shown by the animals of the 50 and 100% treated groups was considered not to have a toxicologically significant effect on the activity of the

nodes.

All nodes of the experimental animals treated at 25% and control group were considered normal in size. Enlarged nodes were found in the groups treated at 50 and 100%.

The slight body weight loss, noted in some experimental animals, was considered not toxicologically significant.

Mean DPM/animal values for the experimental groups treated with test substance concentrations 25, 50 and 100% were 4029, 6576 and 7413 respectively. The mean DPM/animal value for the vehicle control group was 557.

The SI values calculated for the substance concentrations 25, 50 and 100% were 7.2, 11.8 and 13.3 respectively. These results indicate that the test substance could elicit a SI >= 3. No reliable EC3 value could be calculated. It would have been possible to strengthen the outcome of the study by adding lower concentrations. Since the SI values clearly exceeded 3 and since extension of the study would not alter the classification, this was considered not appropriate for ethical reasons.