Registration Dossier

Toxicological information

Direct observations: clinical cases, poisoning incidents and other

Administrative data

direct observations: clinical cases, poisoning incidents and other
Type of information:
other: case report following exposure
Adequacy of study:
supporting study
Study period:
Not specified.
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study was conducted prior to GLP and test guidelines, but sufficient data is available for interpretation of results
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference Type:

Materials and methods

Study type:
clinical case study
Endpoint addressed:
skin sensitisation
Principles of method if other than guideline:
Case reports of 3 employees with dermal irritation/sensitization reactions.
GLP compliance:

Test material

Details on test material:
EPON resins


Case 1 - 26 year old junior laboratory technician reported redness and itching on the backs of both hands. He complained also of a feeling of stiffness of the hands, though clenching was not impeded. He was involved in benchscale plants utilizing epichlorohydrin, hydroxide and bisphenol A in producing DGEBPA. Contact with the uncured resin could occur during equipment breakdown and the clean-up process. He stated he had approximately three contacts/day with uncured resin. At which time he washed his hands with soap and water, followed by acetone, since the material could not be otherwise removed. On examination a macular rash was noted in two discrete areas approximately 2 cm in diameter on the dorsum of his right hand and involving the space between the first finger and thumb. There was moderate edema and erythema, and on palpation small macules were felt. The lesion was treated conservatively, twice daily for four days. The next week the area had entirely cleared. There were no further complaints.

Case 2 - A 23 year-old stock clerk complained swelling of the face and itching of the eyelids. He stated that two days before he had worked for eight hours packaging a liquid EPON and curing agent "A". Four hours after leaving work he had noticed fullness of the eyelids, itching, tearing, and a 'scratching' feeling. On examination, two large erythematous areas were noted, which extended laterally in a fan-shaped area immediately beneath the eyes. The lids were swollen and whitish in appearance, and the palpebral conjunctivae and sclerae were markedly injected. Treatment consisted of application of boric-acid packs to the face twice daily, and ephedrine, 25 mg. t.i.d. Since the packaging procedure was not to be repeated within a week, he was allowed to return to his work area. The condition improved considerably within 48 hours and except for moderate scaling and flaking of the skin, his appearance was normal within 10 days.

Case 3 - A 36-year-old laboratory assistant had a rash on his face and hands. Twelve days previously he had received first-aid treatment for a macular dermatitis on the back of his hands. His job consisted of mixing EPON with a curing agent and applying it with spatula to laminate glass cloth on a roller. After this, the material was cured at about 150F; he was required to handle the hot rolls of finished product. On examination, a typical exematoid dermatitis was observed on the exposed areas. Because of his complaint of intense itching, he was removed from his usual work area for two weeks, during which time he received local treatment, antihistamines and dihydrocortisone. When the dermatitis had cleared, he returned to the work area where a run was in progress. Within minutes the itching and reddening of the eyes recurred. He was assigned to other work for a period of one month, after which a second trial at his former work was made; at the end of a week's time the eczematoid eruption had recurred. While the work habits of this man were satisfactory, the odor of amines was noted in the area of curing, even though the area was hooded. It was decided to transfer the man to another job, and there has been no recurrence of the dermatitis in the past three years.
Route of exposure:
other: dermal and/or inhalation
Reason of exposure:
unintentional, occupational
Exposure assessment:
not specified

Results and discussion

Clinical signs:
see above

Any other information on results incl. tables

Examination of case histories revealed three employees with potential sensitization to DGEBPA.

Applicant's summary and conclusion

Examination of case histories revealed three employees with potential sensitization to DGEBPA.
Executive summary:

Examination of case histories revealed three employees with potential sensitization to DGEBPA.