2,3,5-trimethylphenol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Justification for type of information:

data is from NTRL reports

Data source

Reference

Reference Type:

review article or handbook

Title:

INITIAL SUBMISSION: TOXICITY STUDIES ON: CC 3381 – NONYL PHENOL WITH COVER LETTER DATED 081392

Author:

MONSANTO CO

Year:

1992

Bibliographic source:

OTS0538590, submitted by MONSANTO CO, last updated August 1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: F.H.S.A guidelines

Principles of method if other than guideline:

An acute eye irritation study was performed in rabbits according to F.H.S.A guidelines to assess the irritation potential of p-nonylphenol

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

p-nonylphenol

EC Number:

203-199-4

EC Name:

p-nonylphenol

Cas Number:

104-40-5

IUPAC Name:

4-nonylphenol

Details on test material:

- Name of test material: p-nonylphenol
- Molecular formula: C15-H24-O
- Molecular weight: 220.354
- Smiles notation: c1(ccc(O)cc1)CCCCCCCCC
- InChl: 1S/C15H24O/c1-2-3-4-5-6-7-8-9-14-10-12-15(16)13-11-14/h10-13,16H,2-9H2,1H3
- Substance type: Organic
- Physical state: solid

Specific details on test material used for the study:

- Name of test material (as cited in study report):4-Nonylphenol
- Molecular formula : C15H24O
- Molecular weight : 220.354 g/mol
- Substance type: Organic
- Physical state: Solid

Test animals / tissue source

Species:

rabbit

Strain:

other: New Zealand abino

Details on test animals or tissues and environmental conditions:

No data available

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

0.1 ml

Duration of treatment / exposure:

24 h

Observation period (in vivo):

21 days

Duration of post- treatment incubation (in vitro):

no data available

Number of animals or in vitro replicates:

6

Details on study design:

Scoring System:The eye irritation was scired according to Draize method
The rabbits were scored for ocular lesions at 1,24,481 72, 120, 168h and 21 days

Results and discussion

In vitro

Other effects / acceptance of results:

no data available

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24/48/72 h

Score:

58.2

Max. score:

110

Reversibility:

not specified

Remarks on result:

probability of moderate irritation

Irritant / corrosive response data:

moderately irritating to rabbit eyes

Other effects:

At 10 minutes, moderate erythema, copious discharge .1 hour: iris congestion, severe erythema, slight edema , copious discharge. 24 hours: Areas of slight corneal cloudiness, iris showed little or no reaction to light, severe erythema (necrosis), slight to moderate edema . 48- 168 hr: copious discharge with whitish exudates. 10 days; slight ulceration in 5 rabbits and 21 days : slight ulceration in 2 rabbits , four scored zero

Any other information on results incl. tables

Table : Observations and scores

The maximum score was 110

Hours	1			24			48			72			120			168
Structure	Cornea	Iris	Conjunctivae	Cornea	Iris	Conjunctivae	Cornea	Iris	Conjunctivae	Cornea	Iris	Conjunctivae	Cornea	Iris	Conjunctivae	Cornea	Iris	Conjunctivae
Animal Number
1	0	5	16	40	10	18	40	10	18	20	5	16	20	5	16	20	5	16
2	0	5	16	40	10	18	40	10	18	20	5	16	20	5	14	15	5	14
3	0	5	16	40	10	18	40	10	18	20	5	16	20	5	14	20	5	14
4	0	5	16	40	10	18	40	10	18	20	5	16	20	5	14	15	5	14
5	0	5	16	40	10	18	40	10	18	20	5	16	15	5	14	10	5	12
6	0	5	16	30	5	18	30	5	16	30	5	16	20	5	14	10	5	12
Mean Score	21.0			65.5			64.8			44.3			40.1			33.6

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

The mean irritation score for p-nonylphenol at 1,24, 48,72,120 and 168 hours of observation were 21.0, 65.5, 64.8, 44.3, 40.1 and 33.6 respectively.
The average irritation score after 72 hours was 58.2.
Based on the scores, p-nonyl phenol was considered to be moderately irritating to rabbit eyes.

Executive summary:

An acute eye irritation study was performed in rabbits according to F.H.S.A guidelines to assess the irritation potential of p-nonylphenol.

0.1 ml undiluted p-nonylphenol was instilled into the eyes of 6 New Zealand Albino rabbits for 24 hours. The rabbits were observed for damage to cornea, iris and conjunctivae till 21 days and scored.The following observations were noted till 21 days of observation after instillation of p-nonyl phenol.

At 10 minutes, moderate erythema, copious discharge .1 hour: iris congestion, severe erythema, slight edema , copious discharge. 24 hours: Areas of slight corneal cloudiness, iris showed little or no reaction to light, severe erythema (necrosis), slight to moderate edema . 48- 168 hr: copious discharge with whitish exudates. 10 days; slight ulceration in 5 rabbits and 21 days : slight ulceration in 2 rabbits , four scored zero

The mean irritation score for p-nonylphenol at 1,24, 48,72,120 and 168 hours of observation were 21.0, 65.5, 64.8, 44.3, 40.1 and 33.6 respectively.

The average irritation score after 72 hours was 58.2.

Based on the scores, p-nonyl phenol was considered to be moderately irritating to rabbit eyes.