Butanedioic acid, 2-hydroxy-, 1,4-bis[5,7,7-trimethyl-2-(1,3,3-trimethylbutyl)octyl] ester

Endpoint summary

Description of key information

one in vivo skin sensitisation study (LLNA) available.

one repeated insult patch test with human volunteers available

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Reference 1

Endpoint:

skin sensitisation: in vitro

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available

Reference 2

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

Deviations:

yes

Remarks:

, relative humidity during husbandry was between approx. 30-84%. This deviation did not affect the validity of this study

GLP compliance:

yes (incl. QA statement)

Type of study:

mouse local lymph node assay (LLNA)

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Harlan Netherlands, Horst, NL
- Age at study initiation: 7-8 wks (beginning of acclimatisation)
- Weight at study initiation: 18-22 g
- Housing: single (Makrolon Type I, granulated soft wood bedding)
- Diet (e.g. ad libitum): pelleted standard diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 30 - 84 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To:

Vehicle:

acetone/olive oil (4:1 v/v)

Concentration:

0, 25, 50, and 100 %

No. of animals per dose:

4

Positive control substance(s):

hexyl cinnamic aldehyde (CAS No 101-86-0)

Key result

Parameter:

SI

Value:

3.2

Test group / Remarks:

25 % Test item concentration % (w/v)

Key result

Parameter:

SI

Value:

4.23

Test group / Remarks:

50 % Test item concentration % (w/v)

Key result

Parameter:

SI

Value:

6.75

Test group / Remarks:

100 % Test item concentration % (w/v)

No deaths occurred during the study period, and no symptoms of local toxicity at the ears of the animals and no systemic findings were observed. The body weights of the animals was within the range commonly recorded for this strain and age during the whole study period.

Interpretation of results:

sensitising

Remarks:

Migrated information

Conclusions:

The test item was found to be a skin sensitiser under the described conditions. Since the S.I. was increased above the threshold pf 3 even at the lowest tested concentration an EC3 value could not be derived. The presented study should be considered as adequate and reliable for classification of the test item.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

in addition to the studies above, a study record under section 7.10.4 is available.

Endpoint conclusion is based on this study record.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

The presented information is conclusive but not sufficient for classification.