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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
This study is used for read-across and therefore has been assigned a reliability of 2 (reliable with restrictions). The study, if used in support of terephthalic acid, has a reliability of 1 (reliable without restriction). Limit test performed under GLP requirements.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Principles of method if other than guideline:
The test substance (a neat powder) was administered to the backs of 5 male and 5 female rabbits at a dose level of 2000 mg/kg bw and covered with an occlusive wrap. Prior to application, the backs were shaved and moistened with water. The test substance was left in contact with the skin for 24 hours and then removed. Body weights were assessed at dosing, and on Days 7 and 14. Animals were observed daily for 14 days at which time they were sacrificed and necropsied.
GLP compliance:
yes
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Terephthalic acid
EC Number:
202-830-0
EC Name:
Terephthalic acid
Cas Number:
100-21-0
Molecular formula:
C8H6O4
IUPAC Name:
Terephthalic acid
Details on test material:
Purified terephthalic acid

Test animals

Species:
rabbit
Strain:
other: New Zealand
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Johnson Rabbit Ranch (Wilkinson, IN)
- Age at study initiation: approximately 3 months of age
- Weight at study initiation: 2.59 kg (males) and 2.45 kg (females)
- Housing: Individually in stainless steel cages measuring 61.0 x 45.5 x 41.0 cm. Poly pads were placed in the pan below the stainless steel mesh floor of each animal cage to absorb liquids.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 4 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23.7°C
- Humidity (%): 32%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Prior to application, the backs were shaved and moistened with water. Body weights were assessed at dosing, and on Days 7 and 14. Animals were observed daily for 14 days at which time they were sacrificed and necropsied.

TEST SITE
- Area of exposure: The shaved application site (approximately 240 cm2 on the back of each rabbit) was pre-moistened with water immediately prior to test article administration.
- % coverage: The test substance was covered with a 12.8 x 23.0 cm surgical dressing
- Type of wrap if used: Plastic film, secured by lint-free cloth and elastic adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The skin was wiped gently with gauze and 0.9% saline to remove residual test article.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 g
- For solids, paste formed: The shaved application site was pre-moistened with water immediately prior to test substance administration.
Duration of exposure:
24 hours
Doses:
2 grams
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All test rabbits were observed approximately 3/4, 3-1/4, 4-1/4 and 5-1/4 hours after dosing and at least once per day for 14 days after removal of the wrappings.
- Necropsy of survivors performed: Yes, a limited gross necropsy was performed on all test animals.
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: Body weights were assessed at dosing, and on Days 7 and 14.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred during the study.
Clinical signs:
other: The only clinical signs noted consisted of an erythema at the application site immediately after unwrapping in 2/5 males and 4/5 females.
Gross pathology:
No gross pathological lesions attributable to treatment were evident in any of the rabbits at necropsy.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Rabbit dermal LD50 > 2000 mg/kg bw
Executive summary:

The test substance (a neat powder) was administered to the backs of 5 male and 5 female rabbits at a dose level of 2000 mg/kg bw and covered with an occlusive wrap. Prior to application, the backs were shaved and moistened with water. The test substance was left in contact with the skin for 24 hours and then removed. Body weights were assessed at dosing, and on Days 7 and 14. Animals were observed daily for 14 days at which time they were sacrificed and necropsied. No deaths occurred during the study. The only clinical signs noted consisted of an erythema at the application site immediately after unwrapping in 2/5 males and 4/5 females. Mean body weights increased during the study. No gross pathological lesions attributable to treatment were evident in any of the rabbits at necropsy. The dermal LD50 was greater than 2000 mg/kg bw.