Registration Dossier

Administrative data

Description of key information

The reaction mass of phenol and 4,4'-isopropylidenediphenol (BPA) contains phenol and BPA. The acute mammalian toxicity of this product is expected to be affected most by the presence of phenol.
PHENOL:
Phenol causes severe chemical burns. The local effects are concentration dependent; occasionally skin necrosis was seen in humans with solutions as dilute as 1%. The threshold concentration for local effects in experimental animals is not clearly stated. Irreversible corneal opacity was found in rabbits caused by 5% aqueous phenolic solution. Classification: Causes burns (R 34)
BPA:
The 2003 EU RAR on BPA concluded:
"However, a recent well conducted animal study clearly shows that BPA is not a skin irritant. A recent well conducted animal study shows that BPA is an eye irritant; effects persisted until the end of the study (day 28 postinstillation) in 1 of 3 rabbits. Overall, taking into account the animal and human evidence, BPA has the potential to cause serious damage to the eyes. Slight and transient nasal tract epithelial damage was observed in rats exposed to BPA dust at 170 mg/m3 for 6 hours. Slight local inflammatory effects in the upper respiratory tract were observed in rats exposed to 50 mg/m3 and 150 mg/m3 of BPA in 2 and 13 week repeat inhalation studies, but were not observed at 10 mg/m3 in the same studies. Taken together with anecdotal human evidence, these data suggest BPA has a limited respiratory irritation potential."
There is no significant new information on irritation/corrosion of BPA in the updated 2008 EU RAR or elsewhere.
Overall, data on phenol and BPA indicate that the reaction mass should be regarded to be corrosive to skin, to cause serious damage to the eye and to have respiratory irritation potential .

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

The reaction mass of phenol and 4,4'-isopropylidenediphenol (BPA) contains phenol and BPA.

For considerations on the analogue approach used please refer to the reporting form attached to section 13 of the IUCLID.

The mammalian toxicity of this product is expected to be affected most by the presence of phenol.

PHENOL:

Data on irritation/corrosivity of phenol in experimental animals and humans are presented in EU-RAR (2006), Section 4.1.2.3-4 (page 86ff). The authors concluded that phenol causes severe chemical burns. 

Phenol: SKIN IRRITATION/CORROSION

Mild to severe chemical burns were observed even after a 1-minute uncovered application of undiluted (molten) phenol in five male and five female rats (Brown et al., 1975). The contact of 0.5 g of phenol moistened with physiological saline with the intact and abraded areas of the skin of the bellies of rabbits for a maximum period of 24 hours produced necrosis of the intact skin (limited documentation; Flickinger, 1976). 

Phenol: EYE IRRITATION

According to OECD Guideline 405 no testing is required for corrosive substances. However, the available data in non-contemporary studies confirmed the corrosive properties of phenol (Flickinger, 1976). Rabbits received instillations of 100 mg phenol into the conjuntival sac. Examination of the exposed eyes 24 hours following exposure showed severe conjunctivitis, iritis, corneal opacities occluding most of the iris, and corneal ulcerations extending over the entire corneal surface. There was almost no perceptible improvement in the condition of the eyes during the observation period, and by the 14th day all of the exposed eyes exhibited keratoconus and pannus formation. 

Phenol: HUMAN DATA

Initial skin contact with phenol produces a white wrinkled discoloration with no experience of pain due to the local anaesthetic properties of phenol, with the affected area turning brown and subsequently becoming gangrenous. Ten percent solutions regularly produce corrosion, and occasionally skin necrosis is seen with solutions as dilute as 1% (Kania, 1981; IUCLID Section 7.10.3). Concentrated solutions are severely irritating to the eyes and cause conjunctival swelling with the cornea becoming white and hyperaesthetic; loss of vision has occurred in some cases. Concentration is more critical than volume with respect to local response (Kania, 1981; IUCLID Section 7.10.3).

BPA:

The 2003 EU RAR concluded: "Limited human anecdotal information of uncertain reliability is available from written industry correspondence suggesting that workers handling BPA have in the past experienced skin, eye and respiratory tract irritation. It cannot be determined whether the reported skin reactions were related to skin sensitisation or irritation. However, a recent well conducted animal study clearly shows that BPA is not a skin irritant. A recent well conducted animal study shows that BPA is an eye irritant; effects persisted until the end of the study (day 28 postinstillation) in 1 of 3 rabbits. Overall, taking into account the animal and human evidence, BPA has the potential to cause serious damage to the eyes. Slight and transient nasal tract epithelial damage was observed in rats exposed to BPA dust at 170 mg/m3for 6 hours. Slight local inflammatory effects in the upper respiratory tract were observed in rats exposed to 50 mg/m3and 150 mg/m3of BPA in 2 and 13 week repeat inhalation studies, but were not observed at 10 mg/m3in the same studies. Taken together with anecdotal human evidence, these data suggest BPA has a limited respiratory irritation potential."

There is no significant new information on irritation/corrosion of Bisphenol A in the updated 2008 EU RAR or elsewhere.


Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Effects on respiratory irritation: irritating

Justification for classification or non-classification

The constituent phenol is corrosive to skin and causes severe damage to the eye. The constituent BPA causes severe damage to the eye and respiratory irritation. Therefore, the reaction mass will be classified with: Causes burns (R 34) according to DSD and Skin Corr. 1A, Eye Damage 1 and STOT SE 3 (H335 : May cause respiratory irritation) according to CLP.