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Administrative data

Description of key information

Terphenyl, hydrogenated was very well tolerated in rats after both dermal and ocular testing for irritation and corrosion according to the Draize method. Scores were 0.1 on a scale of 8 for skin irritation and 0.3 on a scale of 110 for eye irritation.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: In compliance with 21 CFR Part 58, available as unpublished report, no restrictions, adequate for assessment.
Principles of method if other than guideline:
Method: Draize Test
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Isaac's Farm Isf
- Age at study initiation: approximately 10 weeks
- Weight at study initiation: 1.91-2.90 kg
- Housing: one per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

Type of coverage:
occlusive
Preparation of test site:
other: shaved and abraded
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL to each application site
Duration of treatment / exposure:
24 hours
Observation period:
14 days
Number of animals:
6 rabbits (3 males and 3 females)
Details on study design:
TEST SITE
- Area of exposure: one inch square, two sites
- Type of wrap if used: latex rubber

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the excess material was wiped
- Time after start of exposure: 24 hours

SCORING SYSTEM: Primary irritation index (Draize procedure)
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24,72 hours
Score:
0.1
Max. score:
8
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24,72 hours
Score:
0.1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24,72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible
Interpretation of results:
GHS criteria not met
Conclusions:
Mean PDI = 0.1 on a scale of 8
Executive summary:

A primary irritation score (mean of 24 and 72h) of 0.1 on a scale of 8.0 was calculated following a 24-hour dermal exposure of hydrogenated terphenyl to the intact and abraded skin of six rabbits. No apparent signs of systemic toxicity were observed.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study appears to be in non-compliance with 21 CFR Part 58 but is appropriate to assess potential eye irritation from ocular contact.
Principles of method if other than guideline:
Draize method
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Isacc's Farm, Litchfield, Illinois
- Age at study initiation: approximately 10 weeks
- Weight at study initiation: 2 to 3 kg
- Housing: One per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
6 animals (3 Males and 3 Females)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): eyes were not rinsed after test material administration

Reading times: 24, 48 and 72 hours

SCORING SYSTEM: Draize score

TOOL USED TO ASSESS SCORE: fluorescein
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72h
Score:
0.06
Max. score:
4
Reversibility:
fully reversible within: 48h
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72h
Score:
0
Max. score:
2
Irritation parameter:
other: Draize score
Basis:
mean
Time point:
other: 24, 48, 72h
Score:
0.3
Max. score:
110
Reversibility:
fully reversible within: 48h
Interpretation of results:
GHS criteria not met
Conclusions:
Mean Draize socre = 0.3 on a scale of 110
Executive summary:

When 0.1 mL of undiluted Terphenyl, hydrogenated was instilled into the conjunctival sac of the rabbit eye, the average of the Draize irritation score for 24, 48 and 72 hours was 0.3 on a scale of 110 in six rabbits. Minor corneal involvement was observed in one eye during the study. All treated eyes had regained a normal appearance by the second day of observation.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

A key study for skin irritation was performed in rats with Terphenyl, hydrogenated (Branch et al., 1980); the study was conducted according to Draize method, and was considered to be reliable, adequate and relevant. A primary irritation score (mean of 24 and 72h) of 0.1 on a scale of 8.0 was calculated following a 24-hour dermal occlusive exposure of Terphenyl, hydrogenated to the intact and abraded skin of six rabbits. No apparent signs of systemic toxicity were observed. A supporting study was available in rabbits, however the reliability was low (Klimisch score 4) as there were no data on the test material composition. The primary irritation score following a 24-hour dermal exposure to the skin was 2 on a scale of 8.0 (Clarks et al., 1979). Another study was not further considered for safety assessment (Monsanto, IBT study, 1970). IBT studies are considered to be unreliable unless otherwise stated (as documented in the OECD HPV manual).

A key study for eye irritation was performed in rats with terphenyl, hydrogenated (Branch et al., 1980); the study was conducted according to Draize method, and was considered to be reliable, adequate and relevant. When 0.1 mL of undiluted Terphenyl, hydrogenated was instilled into the conjunctival sac of the rabbit eye, the average of the Draize irritation scores for 24, 48 and 72 hours was 0.3 on a scale of 110 for six rabbit eyes. Minor corneal involvement was observed in one eye during the study. All treated eyes had regained a normal appearance by the second day of observation. Another study was available (Monsanto, IBT study, 1970), however it was not taken into account for safety assessment for the same reason as above. 

Justification for classification or non-classification

The endpoint does not meet classification criteria according to EU and/or CLP criteria.