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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: study performed in accordance with an official guideline; also a positive control test was performed with a known sensitzer that proved the validity of the test system; GLP-conformity is given

Data source

Reference Type:
study report

Materials and methods

Test guideline
according to guideline
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Chemical structure
Reference substance name:
4-tert-butylbenzoic acid
EC Number:
EC Name:
4-tert-butylbenzoic acid
Cas Number:
Molecular formula:
4-tert-butylbenzoic acid
Details on test material:
- Name of test material (as cited in study report):
- Supplier: presumably the sponsor (Clariant)
- Analytical purity: 99.6 % (HPLC)
- Batch Nr.: 021004
- Stability: stable under storage conditions; expiration date Nov 2003
- Stability of test item dilution: unknown in PEG 300 and in a 1:1 (v/v) mixture of FCA/physiological saline; is excluded from the statement of compliance
- Storage conditions: at room temperature away from direct sunlight in original container

In vivo test system

Test animals

guinea pig
other: Ibm: GOHI; SPF-quality guinea pigs (synonym: Himalayan spotted)
Details on test animals and environmental conditions:
Number of animals for main study/pretest: 15 females / 3 females (nulliparous and non-pregnant)
Age at pretest start / beginning of acclimatization period: 5-7 weeks
Body weight at pretest start: pretest groups 411-442 g; Body weight at beginning of acclimatization period: control and test group 378-426 g
Identification: by unique cage number and corresponding ear tags.
Randomization: selected by hand at time of delivery; no computer randomization.

Acclimatization: one week for the control and test group under test conditions after health examination. No acclimatization for the animals of the pre-
test. Only animals without any visible signs of illness were used for the study.

- Housing: individually in Makrolon type-4 cages with standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz)
- Diet: ad libitum, pelleted standard Provimi Kliba 3418, batch no. 64/02, guinea pig breeding / maintenance diet, containing Vitamin C (Provimi Kliba AG, CH-4303 Kaiseraugst). Results of analyses for contaminants are archived at RCC Ltd, Itingen, CH.
- Water: ad libitum, community tap water from Füllinsdorf. Results of bacteriological, chemical and contaminant analyses are archived at RCC Ltd, Itingen.

Environmental conditions:
- Temperature (°C): 20 +/- 3
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 / 12 (music played during daytime light period)

Study design: in vivo (non-LLNA)

intradermal and epicutaneous
other: Polyethylene glycol 300 (PEG 300), Freund's Complete Adjuvant (FCA), physiological saline
epicutaneous, occlusive
other: Polyethylene glycol 300 (PEG 300), Freund's Complete Adjuvant (FCA), physiological saline
No. of animals per dose:
control group: 5
test group: 10
Positive control substance(s):
alpha-hexylcinnamaldehyde, purity 85 %, from Aldrich Chemicals Company Inc., USA

Study design: in vivo (LLNA)

Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

Positive control results:
It is stated in the study report that based on the findings and in accordance with Commission Directive 96/54/EEC, alpha-hexylcinnamaldehyde does have to be classified and labelled as skin sensitizer and proved the sensitivity of the test system.

Any other information on results incl. tables

Results main study:

Skin effects after intradermal induction (Day 1):

Erythema, oedema, necrotizing dermatitis, encrustation and exfoliation of encrustation were observed as expected (effects of FCA)

Skin effects after epidermal induction (Day 8):

Control group: no erythematous or oedematous reaction was observed in the animals treated with PEG 300 only.

Test group: Discrete/patchy erythema (score = 1) was observed in six out of 10 animals at the 24- and 48-hour reading after treatment with the test item at 50 % in PEG 300.

Skin effects after the challenge (Day 22):

Control group: no skin reactions were observed in the animals when treated with PEG 300 only or when treated with the test item at 25 % in PEG 300.

Test group: no skin reactions were observed in the animals when treated with PEG 300 only or when treated with the test item at 25 % in PEG 300.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Migrated information
It was concluded in the study report:
Based on the findings of the study and in accordance with Commission Directive 96/54/EEC, p-tert-butyl benzoic acid does not have to be classified and labelled as a skin sensitizer.