Registration Dossier

Toxicological information

Sensitisation data (human)

Currently viewing:

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Active sensitization and occupational allergic contact dermatitis caused by para-tertiary-butylcatechol
Author:
Estlander T., Kostiainen M., Jolanki R., Kanerva L.
Year:
1998
Bibliographic source:
Contact Dermatitis, 38(2), 96-100

Materials and methods

Type of sensitisation studied:
skin
Study type:
case report
Principles of method if other than guideline:
Patch-test
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
4-tert-butylpyrocatechol (4-TBC) was supplied by Trolab (Germany). No other data available

Method

Type of population:
occupational
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 9
- Sex: men and women
- Age: 30-52 years
- Race: no data
- Demographic information: no data
Clinical history:
- Exposure time before symptoms:
patients n°1 and 2: 5 years, occasionally
patients n°3, 5, 6 and 8: no previous exposure
patients n°4 and 7: 14 years
patient n°9: 2 years
- Atopy: yes for patients n°5 and 8

Route of administration:
dermal
Details on study design:
TYPE OF TEST USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: occlusive epicutaneous
Finn Chamber method using the European standard series
- Vehicle / solvent: water (patients n°1 and 2) / petrolatum (patients n°3, 4, 5, 6, 7, 8 and 9)
- Concentrations: patients n°1 and 2: from 0.00001% to 1% ; patients n°3, 4, 5, 6, 7, 8 and 9: 1%

EXAMINATIONS
- Grading/Scoring system: from - (negative) to +++ (highly sensitive)
- Statistical analysis: no

Results and discussion

Results of examinations:
SYMPTOMS
- Frequency, level, duration of symptoms observed:
Patient n°1: When the patient was fitting a pump in the pipeline containing 4-TBC 85% in water, the solution accidentally spilled onto his face and hands and he did not wash immediately. On the following day, a reddish, oedematous dermatitis appeared on his face and arms. During sick-leave, the skin symptoms disappeared. Later, the dermatitis reappeared when he worked at the same work site.
Patient n°2: When the patient was changing an automatic valve in the same pipeline as patient n°1, he was suddenly covered by steam containing chemical escaping from the pipeline. By the following morning, an itchy, reddish, oedematous dermatitis with vesicles had appeared on his upper limbs, face and chest.

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 9; 4 of the 9 patients (patients n°1, 2, 4 and 7) developed reactions to 4-TBC which remained positive during the 4-6 day readings.
- Number of subjects with negative reactions: 0
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 0


Any other information on results incl. tables

RESULTS AT 1%:
Patient (n°): reaction
1: (not tested)
2: +++
3: +++
4: ++
5: ++
6: +
7: ++
8: +++
9: ++

RESULTS IN PATIENTS n° 1 AND 2 AT LOWER CONCENTRATIONS:
Concentration (%): reaction in patient 1 / patient 2
0.5: +++ / (not tested)
0.2: +++ / (not tested)
0.1: +++ / +++
0.01: +++ / +++
0.001: +++ / ++
0.0005: (not tested) / ++
0.0001: +(?) / -
0.00001: - / -



Applicant's summary and conclusion

Conclusions:
4-tert-butylpyrocatechol caused skin sensitization reaction in all workers exposed.