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Description of key information

Key value for chemical safety assessment

Skin sensitisation

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Endpoint:
skin sensitisation
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1975
Qualifier:
no guideline followed
Principles of method if other than guideline:
Guinea pigs treated dermally with induction and challenge exposure to the test article or positive control. Each animal served as its own negative control. Skin reactions were recorded after the challenge exposure.
GLP compliance:
no
Type of study:
other:
Species:
guinea pig
Strain:
not specified
Sex:
male
Details on test animals and environmental conditions:
12 male albino guinea pigs weighing 326-393 g were used. The animals were divided into 2 groups consisting of a positive control group (n=4) and 1 treated group (n=8). Animals were housed idividually in suspended metal cages in an air conditioned roome. Food and water were available ad libitum. Observations were made daily.
Positive control results:
All 4 guinea pigs exhibited a response to the challenge dose greater than that obtained in the sensitizing doses. The % range of challenge result was from approximately 121 to 194% of the average values obtained during the sensitizing portion of the study.
Interpretation of results:
sensitising
Remarks:
Migrated information
Conclusions:
Under the conditions of the test, the test article induced skin sensitization in guinea pigs.
Executive summary:

Under the conditions of the test, TBPA induced skin sensitization in guinea pigs.

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
June 1986 - August 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study performerd under GLPs using an established methodology (Buehler).
Principles of method if other than guideline:
Group sizes were 20 animals for the test group and 10 animals for the naive control group. Approximately 2 weeks after the last induction session, the test material prepared as a 50% w/v formulation in acetone was reapplied to the test animls for 5 and 3/4 hours. The test material was also applied to 10 naive control animals. The next day the sites were depilated and scored for severity of response 24 and 48-hrs after removal of the patches.
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
Endpoint addressed using pre-existing data,dating from 1986.
Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
Hartley albino guinea pigs from Murphy Breeding Laboratories, Inc. were used (275-350 g). Animals were acclimated for 7 days after arrival at the test laboratory. Tap water and Purina Guinea Pig Chow were available ad libitum. Animals were housed singly in wire mesh suspension cages and maintained on a 12/12 hr light/dark cycle. Animals were identified by numbered cage cards.
Route:
epicutaneous, occlusive
Vehicle:
other: acetone
Concentration / amount:
95% w/v formulation
Route:
epicutaneous, occlusive
Vehicle:
other: acetone
Concentration / amount:
95% w/v formulation
No. of animals per dose:
10M/10F in the test group. 5M/5F in the naive control-primary challenge group. 5M/5F in the naive control rechallenge group.
Details on study design:
Prior to induction and challenge, the test material was tested for primary irritation in guinea pigs as 95%, 50%, 25% and 10% w/v formulations in acetone. On the day before application, the animals' backs were clipped with electric clippers. On the following day, animals were placed in stainless steel restrainers and patches were applied to each animal. The patches, incorporating a 25 mm Hill Top Chamber, were moistened with 0.3 ml of one of the test formulations. The patches were occluded with dental dam placed over the back of each animal and secured with metal clips. The animals were restrained for 6 hrs and returned to their cages. On the following day, the clipped areas were depilated with NEET CREAM HAIR REMOVER. The cream remained in place for 8 minutes afterwhich it was removed with warm tap water. The patch sites were were scored at 24- and 48hrs without additional depliation using the following scale: 0=no reaction; +=slight patchy erythema (Grades of +/- are equal to 0.5 for calculating the mean); 1=slight confluent or moderate patchy erythema; 2=moderate erythema, 3=severe erythema with or without edema. The test material as a 95% w/v formulation in acetone was chosen for induction, while a concentration of 50% w/v in acetone was chosen for primary challenge.
Positive control substance(s):
no
Positive control results:
Not specified
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50%
No. with + reactions:
5
Total no. in group:
20
Clinical observations:
Grade 1 reactions in 5 animals.
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 5.0. Total no. in groups: 20.0. Clinical observations: Grade 1 reactions in 5 animals..
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50%
No. with + reactions:
5
Total no. in group:
20
Clinical observations:
Grade 1 reactions in 5 animals.
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 5.0. Total no. in groups: 20.0. Clinical observations: Grade 1 reactions in 5 animals..
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
5%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
5%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
Dose level:
5%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
5%
No. with + reactions:
2
Total no. in group:
20
Clinical observations:
Grade 1 reactions in 2 animals.
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 5%. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: Grade 1 reactions in 2 animals..
Interpretation of results:
sensitising
Remarks:
Migrated information
Conclusions:
The test material induced skin sensitization in guinea pigs under the conditions of the test.
Executive summary:

TBPA was positive for skin sensitization when tested in the Buehler guinea pig test.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

TBPA induced skin sensitization in the guinea pig. However, a patch test in humans was negative (see Section 7.10.4)


Migrated from Short description of key information:
TBPA was positive for skin sensitization in the guinea pig.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available study data classification Skin Sensitisation Category 1, H317 is required in accordance with Regulation 1272/2008 (CLP).