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Diss Factsheets

Administrative data

Description of key information

In vivo skin irritation (rabbit)

In vivo eye irritation (rabbit)

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
Study period:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
other: US EPA. "Primary dermal irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978.
Deviations:
not specified
GLP compliance:
not specified
Specific details on test material used for the study:
TEST MATERIAL (as stated in study report): TK 12 184

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Sponsor / Batch No. 312-187
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: in house
- Age at study initiation: adult
- Weight at study initiation: 2 - 3 kg
- Housing: individually in metal cages
- Diet (e.g. ad libitum): Standard rabbit food - NAFAG, No. 814, Gossau SG, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum of 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2 deg C
- Humidity (%): 55 +/- 10 %
- Photoperiod (hrs dark / hrs light): 12 / 12
Type of coverage:
occlusive
Preparation of test site:
other: abraded and intact sites on each animal
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 mL per test site
Duration of treatment / exposure:
24 h
Observation period:
14 d
Number of animals:
3 males and 3 females
Details on study design:
Before treatment the entire back and the flank of the rabbits were shaved with an electric clipper and immediately before treatment the shaven skin on one side was slightly scarified with the help of a "SchröpfSchnapper", Aesculap, Switzerland. Gauze patches of 2.5 x 2.5 cm laden with 0.5 ml of the test material were applied to the prepared abraded and intact skin. The patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape.

Skin reactions were scored using the Draize system.

Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 / 72 hr
Score:
3.8
Max. score:
5
Reversibility:
fully reversible within: 14 d
Remarks on result:
probability of moderate irritation
Irritant / corrosive response data:
The erythema was greater than the site of application in all animals at the two first readings and in some after 72 hours and after 4 days. One animal had slightly ischaemic areas around the sites of application after 3-7 days. After 4 days slightly cracked skin was observed in 3/12 application sites. After 7 days on all animals a scale formation was seen which persisted in 5/12 sites up to 14 days.
Other effects:
Besides a slight sedation for two and frequent ventral recumbency for one day at the beginning of test no signs of intoxication were observed.
Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
Under these test conditions TK 12 184 was found to cause a moderate irritation when applied to intact and abraded rabbit skin. The calculated primary irritation index was 3.8. Changes were fully reversible within 14 days.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: US EPA) "Primary eye irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978.
Deviations:
not specified
GLP compliance:
not specified
Specific details on test material used for the study:
TEST MATERIAL (as stated in study report): TK 12 184

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Sponsor / Batch No. 312-187
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: in house
- Weight at study initiation: 2 - 3 kg
- Housing: individually in metal cages
- Diet (e.g. ad libitum): Standard rabbit food - NAFAG, No. 814, Gossau SG, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum of 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2 deg C
- Humidity (%): 55 +/- 10 %
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: To:
Vehicle:
unchanged (no vehicle)
Controls:
other: right eye
Amount / concentration applied:
0.1 mL
Observation period (in vivo):
14 d
Number of animals or in vitro replicates:
6 animals - unwashed
3 animals - washed
Details on study design:
The test material was inserted into the conjunctival sac of the left eye of the rabbits and the lids were gently closed for a few seconds. The right eye was not treated and served as an untreated control. In 3 of the 9 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of physiological saline. The eye irritation was appraised with a slit-lamp on day 1, 2, 3, 4, 7, 10 and 14 and was scored for each individual rabbit (Draize scoring system).
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
24 h
Score:
6
Max. score:
20
Reversibility:
fully reversible within: 14 days
Irritant / corrosive response data:
Unrinsed eyes:
Besides a slight irritation of the cornea (Grade 1) in one animal after 24 hours no irritation of cornea or iris was observed. Conjunctival irritation returned to normal within 14 days. The maximum mean score of 6.0 was observed after 24 hours. Grade 2 conjunctival irritation occurred in a single unwashed eye and a single washed eye at 24 hours only.
Rinsed eyes;
No irritation of cornea or iris was seen. Conjunctival irritation returned to normal within 14 days. The maximum mean score of 3.3 was observed after 24 hours.
Other effects:
A slight sedation was observed in some animals for 7 days, thereafter only one animal was slightly sedated until day 13.
Interpretation of results:
GHS criteria not met
Remarks:
not an eye irritant by GHS criteria
Conclusions:
Under these standard test conditions, TK 12 184 was mildly irritating to the rabbit eye, producing a maximum mean irritation score of 6.0 in unrinsed rabbit eyes and 3.3 in rinsed eyes. All eyes returned to normal within 14 days.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In vivo skin irritation (rabbit): moderate irritation, primary irritation index = 3.8.  Changes were fully reversible within 14 days.

In vivo eye irritation (rabbit): mildly irritating, maximum mean irritation score of 6.0 in unrinsed rabbit eyes and 3.3 in rinsed eyes. All eyes returned to normal within 14 days.

Justification for classification or non-classification

Based on the available data, TGEPO is classified as Category 2 for skin irritation according to Regulation (EC) No 1272/2008.